EXPERT CTO: Evaluation of the XIENCE PRIME™ LL and XIENCE... | NCT01435031

Label	Type	Description	Intervention Names
CTO Treatment	Other	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation	Device: CTO Treatment Device

Name	Type	Description	Arm Group Labels	Other Names
CTO Treatment Device	Device	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Measure	Description	Time Frame
Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set)	The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.	1 year
Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per Protocol Set)	The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.	1 year
Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI)	Successful recanalization of the CTO defined as: Confirmation of placement of the guide wire in the distal true lumen (component 1) Absence of in-hospital MACE, based on ARC MI (component 2)	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI)	Successful recanalization of the CTO defined as: Confirmation of placement of the guide wire in the distal true lumen (component 1) Absence of in-hospital MACE, based on protocol MI (component 2)	Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes
Percentage of Participants With Angioplasty Predilatation-related: Successful Predilatation of the CTO

Measure	Description	Time Frame
Minimum Lumen Diameter (MLD): Pre-procedure	Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter. MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during Quantitative coronary angiography (QCA) by the Angiographic Core Laboratory.

Eligibility Module

Eligibility Criteria

General Inclusion Criteria:

Subject is ≥ 18 years of age at the time of consent.
Subject is experiencing clinical symptoms considered suggestive of ischemic heart disease (e.g., chest pain or discomfort, heart failure, etc.) or has evidence of myocardial ischemia (e.g., abnormal functional study) attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization.
Subject is eligible and consents to undergo percutaneous coronary intervention (PCI procedure).
Subject is an acceptable candidate for percutaneous transluminal coronary angioplasty (PTCA), stenting, and emergency coronary artery bypass grafting (CABG).
Subject is willing and able to sign an informed consent form (ICF) approved by a local Institutional Review Board/Ethics Committee and to follow the protocol with up to 5-year follow up.
Female subjects of child-bearing potential must have a negative qualitative or quantitative pregnancy test within 7 days before enrollment and effective birth control must be used up to 1 year following the index procedure.

Angiographic Inclusion Criteria

A maximum of one de novo lesion with at least one target segment in a native coronary vessel meeting definition of chronic total occlusion. A "chronic total occlusion" is any non-acute total coronary occlusion fulfilling the following angiographic characteristics and estimated in duration at least 3 months by clinical history and/or comparison with antecedent angiogram or electrocardiogram:
- High-grade native coronary stenosis
- TIMI 0 or 1 antegrade flow
Occluded segment suitable for placement of coronary stents:
- Segment without severe tortuosity (angulation ≥ 45º)
- Segment not located in an excessively distal location

General Exclusion Criteria

Candidates will be excluded from the study if any of the following conditions are present:

Patients with any history of allergy to iodinated contrast that cannot be effectively managed medically, or any known allergy to clopidogrel bisulfate (Plavix®), aspirin, heparin, stainless steel, or everolimus
Evidence of acute myocardial infarction (MI) within 72 hours of the intended treatment (defined as: Q-wave or non-Q-wave MI having creatine kinase (CK) enzymes 2 × the upper limit of normal (ULN) with the presence of a creatine kinase myocardial-band isoenzyme (CK-MB) above the Institution's ULN, or troponin (I or T) above the Institution's ULN)
Previous coronary interventional procedure of any kind within the 30 days prior to the procedure in the target vessel
Planned interventional treatment of either the target or any non-target vessel within 30 days post-procedure
Planned interventional treatment of either the target or any non-target vessel within 6 months post-procedure with any alternative drug eluting stent (DES) (e.g., CYPHER Sirolimus-Eluting stent, TAXUS Paclitaxel-Eluting stent or Endeavor Zotarolimus-Eluting Endeavor stent)
Any contraindication to cardiac catheterization or to any of the standard concomitant therapies used during routine cardiac catheterization and PCI (e.g., aspirin, clopidogrel, unfractionated heparin)
Target lesion requires treatment with a device after successful crossing other than PTCA prior to stent placement (including, but not limited to directional or rotational coronary atherectomy, excimer laser, thrombectomy, etc.). Note: Use of alternative technologies to conventional guide wires that are approved by the United States Food and Drug Administration for CTO revascularization (e.g., Asahi Tornus and Corsair catheters, IntraLuminal Therapeutics Safe Cross guide wire, Flowcardia CROSSER system) is permitted and will be collected in the case report form.
Patients with history of clinically significant abnormal laboratory findings including:
- Neutropenia (<1000 neutrophils/mm3) within the previous 2 weeks, or
- Thrombocytopenia (<100,000 platelets/mm3), or
- Aspartate Transaminase (AST), Alanine Aminotransferase (ALT), alkaline phosphatase, or bilirubin > 1.5 × ULN, or
- Serum creatinine > 1.5 mg/dL
Patients with evidence of ongoing or active clinical instability including the following:
- Sustained systolic blood pressure < 100 mmHg or cardiogenic shock
- Acute pulmonary edema or severe congestive heart failure
- Suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade
- Suspected dissecting aortic aneurysm
- Hemodynamically significant valvular heart disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease
Target lesion involves a bifurcation including a diseased side branch ≥2.25 mm in diameter that would require treatment
Target vessel with a patent bypass graft from prior coronary bypass surgery
Proximal coronary stenting of target lesion
History of stroke or transient ischemic attack within the prior 6 months
Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
History of bleeding diathesis or coagulopathy or refusal of blood transfusions
Patients with any other pathology such as cancer, mental illness, etc., which in the opinion of the Investigator, might put the patient at risk, preclude follow-up, or in any way confound the results of the study.
Known previous medical condition yielding expected survival less than 1 year.
Patients who are unable or unwilling to comply with the protocol or not expected to complete the study period, including its follow-up requirements.
Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires coronary angiography, intravascular ultrasound (IVUS), or other coronary artery imaging procedures

Angiographic Exclusion Criteria

Candidates will be excluded from study if any of the following conditions are met:

Occlusion involves segment within previous stent
Extensive lesion-related thrombus (TIMI thrombus grade 3 or 4)
Previous stenting (drug-eluting or bare metal) in the target vessel unless the following conditions are met:
- It has been at least 9 months since the previous stenting.
- That target lesion is at least 15 mm away from the previously placed stent.
- The previously stented segment (stent plus 5 mm on either side) has no more than 40% diameter stenosis.
The target vessel has other lesions proximal to the total occlusion identified with greater than 40% diameter stenosis based on visual estimate or on-line quantitative coronary angiography (QCA). However, planned stenting of the lesion in target vessel which is proximal to the target lesion and can be covered by a single stent (ie, tandem lesions) are acceptable.

Exclusion Criteria (Non-target Lesion):

The lesion is located in a native vessel distal to anastomosis with a graft.
The vessel has other lesions with greater than 40% diameter stenosis based on visual estimate or on-line QCA.
The vessel has evidence of thrombus.
The vessel is excessively tortuous.
The lesion has any of the following characteristics:
- Lesion location is aorto-ostial, an unprotected left main lesion, or within 5 mm of the origin of the left anterior descending coronary artery (LAD), left circumflex coronary artery (LCX), or right coronary artery (RCA).
- Involves a side branch > 2.0 mm in diameter.
- Is at or distal to a > 45º bend in the vessel.
- Is moderately to severely calcified.
- TIMI flow 0 or 1.

Name	Affiliation	Role
David E. Kandzari, MD	Piedmont Heart Institute	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Abbott Vascular		Santa Clara	California	95054	United States

PubMed Identifier	Type	Citation	Retractions
25912400	Derived	Kandzari DE, Kini AS, Karmpaliotis D, Moses JW, Tummala PE, Grantham JA, Orr C, Lombardi W, Nicholson WJ, Lembo NJ, Popma JJ, Wang J, Larracas C, Rutledge DR. Safety and Effectiveness of Everolimus-Eluting Stents in Chronic Total Coronary Occlusion Revascularization: Results From the EXPERT CTO Multicenter Trial (Evaluation of the XIENCE Coronary Stent, Performance, and Technique in Chronic Total Occlusions). JACC Cardiovasc Interv. 2015 May;8(6):761-769. doi: 10.1016/j.jcin.2014.12.238. Epub 2015 Apr 22.

ID	Title	Description
FG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per ITT Set)

The primary stent-related endpoint is MACE, defined as death, MI, or clinically-driven TLR at 1 year post-procedure among all enrolled patients, for whom recanalization and pre-dilatation of the target lesion are completed and the study stent(s) (XIENCE V and/or XIENCE PRIME) is inserted into the coronary guiding catheter.

Intention-to-treat (ITT) definition: ITT subjects include all subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and whose target lesion was successfully crossed and predilated.

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000211

Title

Denominators

Categories

Title	Measurements
	OG00039

Primary

Number of Participants With Stent-related: Major Adverse Cardiac Events (MACE) (Per Protocol Set)

Per-protocol (PP) definition: The per-protocol population is defined as all ITT subjects in whom at least 1 study stent was implanted, met procedure success, had available follow up data (i.e. a MACE event within 360 days or follow up of at least 330 days), and did not have major protocol deviations due to inappropriate enrollment.

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units

Primary

Percentage of Participants With Guide Wire-related: Successful Recanalization of the Chronic Total Occlusion (CTO) (MACE Includes Per ARC Definition of MI)

Successful recanalization of the CTO defined as:

Confirmation of placement of the guide wire in the distal true lumen (component 1)
Absence of in-hospital MACE, based on ARC MI (component 2)

All the subjects who met the study entry criteria, signed the written informed consent, were enrolled in the trial and in whom an attempt was made to cross the target lesion with the HT Progress or the HT Pilot guide wires, are included in the ITT population for the guide wire-related analysis.

Posted

Number

95% Confidence Interval

percentage of participants

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units

Primary

Percentage of Participants With Guide Wire-related: Successful Recanalization of the CTO (MACE Includes Per Protocol Definition of MI)

Successful recanalization of the CTO defined as:

Confirmation of placement of the guide wire in the distal true lumen (component 1)
Absence of in-hospital MACE, based on protocol MI (component 2)

Posted

Number

95% Confidence Interval

percentage of participants

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts

Primary

Percentage of Participants With Angioplasty Predilatation-related: Successful Predilatation of the CTO

Successful delivery of the MINI-TREK Coronary Dilatation Catheter to and across the target lesion and;
Successful inflation and deflation of the MINI-TREK Coronary Dilatation Catheter and;
Absence of clinically significant vessel perforation, flow-limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) from baseline or clinically significant arrhythmias requiring medical treatment or device intervention following dilatation with MINI-TREK and;
Achievement of final TIMI flow 3 for the target lesion at the conclusion of the index procedure

Angiographically Evaluable Subjects

Posted

Number

95% Confidence Interval

percentage of participants

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Secondary

Minimum Lumen Diameter (MLD): Pre-procedure

Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.

MLD is the average of 2 orthogonal views (when possible) of the narrowest point within the area of assessment - in lesion, in stent, or in segment. MLD is visually estimated during angiography by the Investigator; it is measured during Quantitative coronary angiography (QCA) by the Angiographic Core Laboratory.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Mean

Standard Deviation

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Minimum Lumen Diameter (MLD): Post-procedure

Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Mean

Standard Deviation

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Percentage of Participants With Change in Thrombolysis in Myocardial Infarction (TIMI) Flow Grade: Pre-procedure

Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.

TIMI Classification:

TIMI 0 No perfusion.

TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run.

TIMI 2 Partial perfusion. Contrast opacifies the entire coronary bed distal to the stenosis. However, the rate of entry and/or clearance is slower in the coronary bed distal to the obstruction than in comparable areas not perfused by the dilated vessel.

TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds.

ITT set.The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Number

95% Confidence Interval

percentage of participants

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Secondary

Percentage of Participants With Change in TIMI Flow Grade: Post-procedure

Pre- and post predilatation with the MINI-TREK Coronary Dilatation Catheter.

TIMI Classification:

TIMI 0 No perfusion.

TIMI 1 Penetration with minimal perfusion. Contrast fails to opacify the entire bed distal to the stenosis for the duration of the cine run.

TIMI 3 Complete perfusion. Filling and clearance of contrast equally rapid in the coronary bed distal to stenosis as in other coronary beds.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Number

95% Confidence Interval

percentage of participants

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Secondary

Percentage of Participants With Device Success

Achievement of <50% diameter stenosis within the target lesion segment using assigned study device

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Number

95% Confidence Interval

percentage of participants

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Procedure Success

Device success and absence of in-hospital MACE.

Per-protocol MI definition: Myocardial infarctions per protocol definition were categorized as Q-wave (development of new, pathological Q waves on the ECG) or non-Q-wave (elevation of CK levels to greater than two times the upper limit of normal and elevated CK-MB in the absence of new pathological Q waves).

Per ARC MI definition: Myocardial infarctions per ARC definition were also categorized as Q-wave (development of new pathological Q waves in 2 or more contiguous leads (according to the Minnesota code) with or without post-procedure CK or CK-MB levels elevated above normal) or non-Q-wave (all MIs not classified as Q-wave). ARC defined MIs were further classified as Periprocedural PCI, Periprocedural CABG, Spontaneous, Sudden Death, and Reinfarction based on biomarker and additional criteria and as ST Elevation MI (STEMI) or Non-ST Elevation MI (NSTEMI) based on ST segment.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Number

95% Confidence Interval

percentage of participants

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Secondary

Percentage of Participants With Procedural Success With Antegrade Crossing

Defined as device success and absence of in-hospital MACE with antegrade crossing technique.

ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.

Posted

Number

percentage of participants

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Procedural Success With Subintimal Tracking and Re-entry (STAR) Technique

Defined as device success and absence of in-hospital MACE with antegrade crossing technique

ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.

Posted

Number

percentage of participants

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Procedural Success With Knuckle Wire

Defined as device success and absence of in-hospital MACE with antegrade crossing technique

ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.

Posted

Number

percentage of participants

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Procedural Success With Primary Retrograde Wire Crossing

Defined as device success and absence of in-hospital MACE with antegrade crossing technique

ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.

Posted

Number

percentage of participants

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Procedural Success With Controlled Antegrade-Retrograde Technique (CART)

Defined as device success and absence of in-hospital MACE with antegrade crossing technique

ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.

Posted

Number

percentage of participants

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Procedural Success With Reverse CART

Defined as device success and absence of in-hospital MACE with antegrade crossing technique

ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.

Posted

Number

percentage of participants

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Procedural Success With Kissing Wire Technique

Defined as device success and absence of in-hospital MACE with antegrade crossing technique

ITT set.The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.

Posted

Number

percentage of participants

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Procedural Success With Sub Intimal Technique

Defined as device success and absence of in-hospital MACE with antegrade crossing technique.

ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.

Posted

Number

percentage of participants

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Procedural Success With Multiple Crossing Techniques

Defined as device success and absence of in-hospital MACE with antegrade crossing technique

ITT set. The number of participants analyzed include the numbers of subjects with corresponding crossing method that were evaluable for procedural success.

Posted

Number

percentage of participants

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Resource Utilization: Procedural Time

ITT set.

Posted

Mean

Standard Deviation

Minutes

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Resource Utilization: Fluoroscopic Time

ITT set.

Posted

Mean

Standard Deviation

Minutes

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Resource Utilization: Contrast Volume

ITT set.

Posted

Mean

Standard Deviation

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With Clinically Significant Perforation

Any perforation resulting in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft or comparable therapy

ITT Set

Posted

Number

95% Confidence Interval

percentage of participants

Participants were monitored for the duration of index procedure, an average of 79.9 ± 48.5 minutes

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Major Adverse Cardiac Events (MACE)

Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Major Adverse Cardiac Events (MACE)

Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Major Adverse Cardiac Events (MACE)

Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Major Adverse Cardiac Events (MACE)

Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

The overall number of participants analysed include ITT subjects who experienced the specific event within 720 days or ITT subjects with follow-up of at least 690 days.

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Major Adverse Cardiac Events (MACE)

Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days.

Posted

Count of Participants

Participants

3 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Major Adverse Cardiac Events (MACE)

Per protocol. Defined as death, MI (Q wave and non-Q wave) or clinically-driven target lesion revascularization.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.

Posted

Count of Participants

Participants

4 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants Experiencing Death

MACE Component; per protocol.

Death is divided into 2 categories:

Cardiac death is defined as death due to any of the following:

Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded.

Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units

Secondary

Number of Participants Experiencing Death

MACE Component; per protocol.

Death is divided into 2 categories:

Cardiac death is defined as death due to any of the following:

Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded.

Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units

Secondary

Number of Participants Experiencing Death

MACE Component; per protocol.

Death is divided into 2 categories:

Cardiac death is defined as death due to any of the following:

Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded.

Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units

Secondary

Number of Participants Experiencing Death

MACE Component; per protocol.

Death is divided into 2 categories:

Cardiac death is defined as death due to any of the following:

Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded.

Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units

Secondary

Number of Participants Experiencing Death

MACE Component; per protocol.

Death is divided into 2 categories:

Cardiac death is defined as death due to any of the following:

Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded.

Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days.

Posted

Count of Participants

Participants

3 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Secondary

Number of Participants Experiencing Death

MACE Component; per protocol.

Death is divided into 2 categories:

Cardiac death is defined as death due to any of the following:

Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded.

Non-cardiac death is defined as a death not due to cardiac causes (as defined above).

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.

Posted

Count of Participants

Participants

4 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Secondary

Number of Participants Experiencing Cardiac Death

TLF component.

Cardiac death was defined as death due to any of the following:

Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants Experiencing Cardiac Death

TLF component.

Cardiac death was defined as death due to any of the following:

Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants Experiencing Cardiac Death

TLF component.

Cardiac death was defined as death due to any of the following:

Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants Experiencing Cardiac Death

TLF component.

Cardiac death was defined as death due to any of the following:

Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants Experiencing Cardiac Death

TLF component.

Cardiac death was defined as death due to any of the following:

Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

3 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants Experiencing Cardiac Death

TLF component.

Cardiac death was defined as death due to any of the following:

Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
Stroke within 30 days of the procedure or stroke suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.

Posted

Count of Participants

Participants

4 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Secondary

Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)

MACE Component;

Myocardial Infarction (per ARC definition)

Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal
Non-Q-wave MI: All MIs not classified as Q-wave.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)

MACE Component;

Myocardial Infarction (per ARC definition)

Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal
Non-Q-wave MI: All MIs not classified as Q-wave.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)

MACE Component;

Myocardial Infarction (per ARC definition)

Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal
Non-Q-wave MI: All MIs not classified as Q-wave.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)

MACE Component;

Myocardial Infarction (per ARC definition)

Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal
Non-Q-wave MI: All MIs not classified as Q-wave.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)

MACE Component;

Myocardial Infarction (per ARC definition)

Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal
Non-Q-wave MI: All MIs not classified as Q-wave.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

3 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Myocardial Infarction Q Wave and Non-Q Wave (MI)

MACE Component;

Myocardial Infarction (per ARC definition)

Q wave MI: Development of new pathological Q waves in 2 or more contiguous leads with or without post-procedure CK or CK-MB levels elevated above normal
Non-Q-wave MI: All MIs not classified as Q-wave.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.

Posted

Count of Participants

Participants

4 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants With Target Vessel-related MI

TLF Component; per ARC

Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Target Vessel-related MI

TLF Component; per ARC

Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Target Vessel-related MI

TLF Component; per ARC

Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Target Vessel-related MI

TLF Component; per ARC

Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Target Vessel-related MI

TLF Component; per ARC

Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

3 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Target Vessel-related MI

TLF Component; per ARC

Target vessel-related MI: All infarcts that cannot be clearly attributed to a vessel other than the target vessel will be considered related to the target vessel.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.

Posted

Count of Participants

Participants

4 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants With Target Lesion Revascularization (TLR)

Repeat percutaneous coronary intervention (PCI) or Coronary artery bypass graft (CABG) to the target lesion/site.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Target Lesion Revascularization (TLR)

Repeat PCI or CABG to the target lesion/site.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Target Lesion Revascularization (TLR)

Repeat PCI or CABG to the target lesion/site.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Target Lesion Revascularization (TLR)

Repeat PCI or CABG to the target lesion/site.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Target Lesion Revascularization (TLR)

Repeat PCI or CABG to the target lesion/site.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

3 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Target Lesion Revascularization (TLR)

Repeat PCI or CABG to the target lesion/site.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

4 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)

TLF and MACE component. Revascularization at the target lesion associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target lesion with diameter stenosis >= 70% by QCA without either angina or a positive functional study.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants With Driven Target Lesion Revascularization (Clinically-Driven TLR)

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

3 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants With Clinically-Driven Target Lesion Revascularization (Clinically-Driven TLR)

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

4 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants With All Target Vessel Revascularization (TVR)

Repeat PCI or CABG of the target vessel. Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants With All Target Vessel Revascularization (TVR)

Repeat PCI or CABG of the target vessel.

Revascularization in the target vessel associated with positive functional ischemia study or ischemic symptoms AND an angiographic minimal lumen diameter stenosis >= 50% by QCA, or revascularization of a target vessel with diameter stenosis >= 70% by QCA without either angina or a positive functional study

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants With All Target Vessel Revascularization (TVR)

Repeat PCI or CABG of the target vessel.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants With All Target Vessel Revascularization (TVR)

Repeat PCI or CABG of the target vessel.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants With All Target Vessel Revascularization (TVR)

Repeat PCI or CABG of the target vessel.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

3 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants With All Target Vessel Revascularization (TVR)

Repeat PCI or CABG of the target vessel.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

4 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants With Target Vessel Failure (TVF)

Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.

Target vessel failure will be reported when any of the following events occur:

Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is determined.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants With Target Vessel Failure (TVF)

Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.

Target vessel failure will be reported when ANY of the following events occur:

Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is determined.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants With Target Vessel Failure (TVF)

Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.

Target vessel failure will be reported when ANY of the following events occur:

Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is determined.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants With Target Vessel Failure (TVF)

Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.

Target vessel failure will be reported when ANY of the following events occur:

Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is determined.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants

Secondary

Number of Participants With Target Vessel Failure (TVF)

Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.

Target vessel failure will be reported when ANY of the following events occur:

Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is determined.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days.

Posted

Count of Participants

Participants

3 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units

Secondary

Number of Participants With Target Vessel Failure (TVF)

Composite endpoint comprised of cardiac death, target vessel MI, or clinically-driven target vessel revascularization. Per protocol.

Target vessel failure will be reported when ANY of the following events occur:

Recurrent MI occurs in territory not clearly attributed to a vessel other than the target vessel.
Cardiac death not clearly due to a non-target vessel endpoint.
Target vessel revascularization is determined.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.

Posted

Count of Participants

Participants

4 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units

Secondary

Number of Participants With Target Lesion Failure (TLF)

Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

30 days

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Target Lesion Failure (TLF)

Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

6 months

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Target Lesion Failure (TLF)

Composite of cardiac death, target vessel-related MI, and clinically-driven TLR. Per protocol.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Target Lesion Failure (TLF)

Composite of cardiac death, target vessel-related MI, and clinically-driven TLR

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Target Lesion Failure (TLF)

Composite of cardiac death, target vessel-related MI, and clinically-driven TLR

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days.

Posted

Count of Participants

Participants

3 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Target Lesion Failure (TLF)

Composite of cardiac death, target vessel-related MI, and clinically-driven TLR

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.

Posted

Count of Participants

Participants

4 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Stent Thrombosis

Academic Research Consortium (ARC) criteria; definite and probable

Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).

Probable stent thrombosis as defined by ARC criteria: Any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

Acute (0-24 hours)

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Secondary

Number of Participants With Stent Thrombosis

Academic Research Consortium (ARC) criteria; definite and probable. Definite stent thrombosis as defined by ARC criteria: Angiographic confirmation with at least one of the following: Acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

Subacute (>24 hours to 30 days)

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Secondary

Number of Participants With Stent Thrombosis

Academic Research Consortium (ARC) criteria; definite and probable.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

Late (>30 days to 1 year)

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Secondary

Number of Participants With Stent Thrombosis

Academic Research Consortium (ARC) criteria; definite and probable.

Definite stent thrombosis as defined by ARC criteria: angiographic confirmation with at least one of the following: acute onset of ischemic symptoms at rest, new ischemic ECG changes that suggest acute ischemia or typical rise and fall of cardiac biomarkers OR pathological confirmation at autopsy or via examination of tissue retrieved following thrombectomy).

Probable stent thrombosis as defined by ARC criteria: any unexplained death within the first 30 days or, regardless of the time after the index procedure, any MI related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation and in the absence of any other obvious cause.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Secondary

Number of Participants With Stent Thrombosis

Academic Research Consortium (ARC) criteria.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Secondary

Number of Participants With Stent Thrombosis

Academic Research Consortium (ARC) criteria.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

3 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Secondary

Number of Participants With Stent Thrombosis

Academic Research Consortium (ARC) criteria.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

Posted

Count of Participants

Participants

4 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Secondary

Number of Participants With Occurrence of Stent Fracture at Target Lesion

Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

The overall number of participants analysed include ITT subjects who experienced the specific event within 360 days or ITT subjects with follow-up of at least 330 days

Posted

Count of Participants

Participants

1 year

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Occurrence of Stent Fracture at Target Lesion

Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

The overall number of participants analysed include ITT subjects who experienced the specific event within 720 days or ITT subjects with follow-up of at least 690 days.

Posted

Count of Participants

Participants

2 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Occurrence of Stent Fracture at Target Lesion

Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

The overall number of participants analysed include ITT subjects who experienced the specific event within 1080 days or ITT subjects with follow-up of at least 1050 days.

Posted

Count of Participants

Participants

3 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Secondary

Number of Participants With Occurrence of Stent Fracture at Target Lesion

Assessed by fluoroscopy in patients undergoing clinically-driven angiographic follow-up.

ITT set. The number of participants analyzed include subjects who had available follow up data at that time frame.

The overall number of participants analysed include ITT subjects who experienced the specific event within 1440 days or ITT subjects with follow-up of at least 1410 days.

Posted

Count of Participants

Participants

4 years

ID	Title	Description
OG000	CTO Treatment	Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO: XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent HT PROGRESS and/or HT PILOT guide wires in recanalization MINI-TREK Coronary Dilatation Catheter in predilatation

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected222 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected222 at risk
Angina pectoris	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00020 affected222 at risk
Angina unstable	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected222 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected222 at risk
Atrial flutter	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Bradycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Cardiac arrest	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected222 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected222 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Coronary artery disease	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected222 at risk
Coronary artery dissection	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected222 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Myocardial infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected222 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected222 at risk
Pericardial effusion	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected222 at risk
Cataract	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Catheter site haematoma	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Catheter site pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Chest pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Death	General disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected222 at risk
Device malfunction	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Fatigue	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Medical device complication	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Non-cardiac chest pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected222 at risk
Thrombosis in device	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Appendicitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Arthritis bacterial	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Chest wall abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Septic shock	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Cardiac procedure complication	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
In-stent coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 affected222 at risk
Ureteric anastomosis complication	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Cardiac enzymes increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Small cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected222 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Presyncope	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Syncope	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Nephropathy	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected222 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected222 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Aortic aneurysm	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Aortic dissection	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Hypotension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Intermittent claudication	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Ischaemia	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Melaena	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Cellulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Bone cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Malignant palate neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Urinary retention	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Arteriosclerosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0008 affected222 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Neutropenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0008 affected222 at risk
Angina pectoris	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00032 affected222 at risk
Arteriospasm coronary	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected222 at risk
Atrial flutter	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Atrioventricular block first degree	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Bradycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected222 at risk
Coronary artery dissection	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG00018 affected222 at risk
Coronary artery perforation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Left ventricular dysfunction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected222 at risk
Pericardial effusion	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected222 at risk
Tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected222 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected222 at risk
Cushing's syndrome	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Ocular hyperaemia	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected222 at risk
Constipation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Mesenteric artery stenosis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Nausea	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Retroperitoneal haematoma	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Retroperitoneal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Swollen tongue	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Umbilical hernia	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Catheter site haematoma	General disorders	MedDRA 10.0	Systematic Assessment	EG00013 affected222 at risk
Catheter site haemorrhage	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Catheter site pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0007 affected222 at risk
Catheter site related reaction	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Chest pain	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Fatigue	General disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected222 at risk
Gait disturbance	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Influenza like illness	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Injection site haemorrhage	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Non-cardiac chest pain	General disorders	MedDRA 10.0	Systematic Assessment	EG00013 affected222 at risk
Oedema peripheral	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Pyrexia	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Thrombosis in device	General disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Bile duct stenosis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Acute sinusitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Bronchitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Device related infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Folliculitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Infected cyst	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Pneumonia	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 affected222 at risk
Sepsis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0003 affected222 at risk
Urinary tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0004 affected222 at risk
Wound infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Cardiac procedure complication	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0005 affected222 at risk
Meniscus lesion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Vascular graft occlusion	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Vascular pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Blood creatine phosphokinase MB increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Cardiac enzymes increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0005 affected222 at risk
Cardiac stress test abnormal	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Electrocardiogram QRS complex abnormal	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Oxygen consumption decreased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Smear cervix abnormal	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Transaminases increased	Investigations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected222 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected222 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected222 at risk
Enthesopathy	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Joint range of motion decreased	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected222 at risk
Sensation of heaviness	Musculoskeletal and connective tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Dizziness	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected222 at risk
Headache	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Paraesthesia	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Presyncope	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Syncope	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected222 at risk
Anxiety	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Confusional state	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Depression	Psychiatric disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Haematuria	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Renal failure acute	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected222 at risk
Renal failure	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Erectile dysfunction	Reproductive system and breast disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected222 at risk
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG00011 affected222 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Sleep apnoea syndrome	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Ecchymosis	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Arteriovenous fistula	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Flushing	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Haematoma	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Haemorrhage	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Hypertension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0004 affected222 at risk
Hypotension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG00010 affected222 at risk
Intermittent claudication	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected222 at risk
Lymphadenopathy mediastinal	Blood and lymphatic system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Angina unstable	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected222 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Cardiac arrest	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected222 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected222 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Coronary artery disease	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0006 affected222 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Coronary artery thrombosis	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Myocardial infarction	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0005 affected222 at risk
Pulseless electrical activity	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Supraventricular extrasystoles	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Ventricular fibrillation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Cataract	Eye disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Diverticular perforation	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Melaena	Gastrointestinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Device malfunction	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Medical device complication	General disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Appendicitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Arthritis bacterial	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Cellulitis	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Chest wall abscess	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Septic shock	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Urinary tract infection bacterial	Infections and infestations	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
In-stent coronary artery restenosis	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 affected222 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Ureteric anastomosis complication	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Bone cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Glioblastoma multiforme	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Lung neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Malignant palate neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Small cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0003 affected222 at risk
Haemorrhage intracranial	Nervous system disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Nephropathy	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Renal artery stenosis	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Urinary retention	Renal and urinary disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Respiratory arrest	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Aortic aneurysm	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Aortic dissection	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Arteriosclerosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Ischaemia	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0002 affected222 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 10.0	Systematic Assessment	EG0001 affected222 at risk

ID	Term
D003324	Coronary Artery Disease
D023921	Coronary Stenosis

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases