BARD® Study of LIFESTREAM™ Balloon Expandable Covered Ste... | NCT02228564

Label	Type	Description	Intervention Names
LIFESTREAM™	Experimental	This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent.	Procedure: Percutaneous transluminal angioplasty (PTA) Device: LIFESTREAM™ covered stent

Name	Type	Description	Arm Group Labels	Other Names
Percutaneous transluminal angioplasty (PTA)	Procedure	Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Measure	Description	Time Frame
Number of Participants With Device and/or Procedure-Related Death or Myocardial Infarction (MI) Through 30 Days, or Any Target Lesion Revascularization (TLR), Target Limb(s) Major Amputation, or Restenosis Through 9-Months Post Index Procedure.	The primary endpoint is a composite safety and effectiveness measure defined as device and/or procedure-related death or myocardial infarction (MI) through 30 days, or any Target Lesion Revascularization (TLR), target limb(s) major amputation, or restenosis through 9-months post-index procedure.	9 months post index procedure

Measure	Description	Time Frame
Number of Participants With Major Adverse Events (MAEs) Through 9-Months Post Index Procedure.	Major Adverse Events (MAE) defined as device and/or procedure-related death or MI through 30 days, or any TLR or target limb(s) major amputation through 9-months post-index procedure. Major amputation is defined as an amputation at or above the ankle.	9 months post index procedure

Eligibility Module

Eligibility Criteria

CLINICAL INCLUSION CRITERIA:

The subject provides written informed consent using an Informed Consent Form approved by the Ethics Committee/ Institutional Review Board for the site.
Subject agrees to comply with the protocol-mandated follow-up procedures and visits.
Subject is a male or non-pregnant female ≥ 21 years old with an expected lifespan sufficient to allow for completion of all study procedures.
Subject has intermittent claudication (Rutherford Category 2-3) or ischemic rest pain (Rutherford Category 4).
Subject is able and willing to comply with any required medication regimen.

ANGIOGRAPHIC INCLUSION CRITERIA:

Subject has evidence of single, bilateral, or multiple de novo and/or restenotic (non-stented) lesion in the native common and/or external iliac artery that is ≥ 50% stenosed (including total occlusions).
The target lesion can be successfully crossed with a guide wire and pre-dilated with an appropriately sized PTA balloon.
The reference vessel diameter is between 4.5 mm -12.0 mm in diameter.
The target lesion is ≤ 100 mm in combined length (per side).
The subject has angiographic evidence of a patent (< 50% stenosis) profunda and/or superficial femoral artery (SFA) in the target limb.

CLINICAL EXCLUSION CRITERIA:

The subject is unable or unwilling to provide written informed consent or to conform to the study protocol follow-up procedures and visits.
The subject is or plans to become pregnant during the study.
The subject is asymptomatic, has mild claudication or critical limb ischemia with tissue loss described as Rutherford Category 0, 1, 5 or 6.
The subject has a vascular graft previously implanted in the native iliac vessel.
The subject suffered a hemorrhagic stroke or transient ischemic attack (TIA) within 3 months prior to the index procedure.
The subject has a known uncorrectable bleeding diathesis or active coagulopathy.
The subject has a serum creatinine ≥ 2.5 mg/dl or is on dialysis.
The subject has a known allergy or sensitivity to stainless steel (i.e., Nickel), ePTFE, or has intolerance to the antiplatelet, anticoagulant or thrombolytic medications required per the protocol.
The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated.
The subject had a prior vascular intervention within 30 days before or planned for within 30 days after the index procedure.
The subject has another medical condition, which may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up.
The subject is currently participating in an investigational drug, biologic, or another device study.

ANGIOGRAPHIC EXCLUSION CRITERIA:

The subject has extensive peripheral vascular disease, which in the opinion of the Investigator, would preclude safe insertion of an introducer sheath. The ipsilateral common femoral artery should be patent (< 50% stenosis).
The target lesion requires treatment other than angioplasty to facilitate subject device delivery.
The subject has severe calcification of the target lesion, preventing inflation of PTA balloon.
The target lesion has been previously treated with a stent (bare or covered).
The subject has angiographic evidence of acute thrombus at the target lesion.
The target lesion involves the origin of the internal iliac artery such that successful treatment of the lesion would require the subject device to cross/occlude the side branch.
The target lesion located in the distal external iliac artery such that successful treatment of the lesion would require the subject device to cross/occlude side branches or be exposed to compressive forces associated with the close proximity to the common femoral artery.
The subject has an abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesion.
The subject has a pre-existing target iliac artery aneurysm or perforation or dissection of the target iliac artery prior to the initiation of the treatment for this study.

Name	Affiliation	Role
John R Laird, M.D.	U. C. Davis Medical Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Arkansas Heart Hospital		Little Rock	Arkansas	72211	United States
Vascular and Interventional Specialists of Orange County

ID	Title	Description
FG000	LIFESTREAM™	This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent. Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 15, 2015

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 Device and/or Procedure-Related Death or Myocardial Infarction (MI) Through 30 Days, or Any Target Lesion Revascularization (TLR), Target Limb(s) Major Amputation, or Restenosis Through 9-Months Post Index Procedure.

The primary endpoint is a composite safety and effectiveness measure defined as device and/or procedure-related death or myocardial infarction (MI) through 30 days, or any Target Lesion Revascularization (TLR), target limb(s) major amputation, or restenosis through 9-months post-index procedure.

The number of participants (n) may vary from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Posted

Count of Participants

Participants

9 months post index procedure

ID	Title	Description
OG000	LIFESTREAM™	This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent. Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent

Units	Counts
Participants	OG000138

Title

Denominators

Categories

Title	Measurements
	OG00016

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000	H0: The proportion of subjects in the LifeStream™ Covered Stent group (PBBX) with events in the primary endpoint is greater than or equal to that of the PG of 19.5%. H1: The proportion of subjects in the LifeStream™ Covered Stent group (PBBX) with events in the primary endpoint is less than that of the PG of 19.5%.	Exact binomial test		<0.0325														Non-Inferiority	The sample size calculation assumes the following: The LIFESTREAM™ Covered Stent composite event rate is estimated at 10.5% The Performance Goal is set at 19.5% The Type 1 error, α = 0.05 (one-sided). The Type 2 error, β = 0.10 (Power = 1 - β = 90%). The calculated sample size is 139 subjects to be followed through the 9-month follow-up visit (using nQuery 7.0). To accommodate 10% censoring, the sample size is increased to 154.

Secondary

Number of Participants With Major Adverse Events (MAEs) Through 9-Months Post Index Procedure.

Major Adverse Events (MAE) defined as device and/or procedure-related death or MI through 30 days, or any TLR or target limb(s) major amputation through 9-months post-index procedure. Major amputation is defined as an amputation at or above the ankle.

The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Posted

Count of Participants

Participants

9 months post index procedure

ID	Title	Description
OG000	LIFESTREAM™	This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent. Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent

Units	Counts
Participants

Secondary

Number of Lesions With Acute Lesion Success

Acute Lesion Success defined as attainment of < 30% residual stenosis of the target lesion after the index procedure using any percutaneous method and/or non-investigational device (i.e., post-dilatation), as determined by an Independent Angiographic Core Lab.

Posted

Count of Units

Lesions

At time of Index Procedure

Lesions

ID	Title	Description
OG000	LIFESTREAM™	This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent. Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent

Units	Counts
Participants	OG000

Secondary

Number of Participants With Acute Procedure Success

Acute Procedure Success defined as lesion success and no peri-procedural complications (death, stroke, myocardial infarction (MI), emergent surgical revascularization, significant distal embolization in target limb, and thrombosis of target vessel) prior to hospital discharge.

The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis. In this instance, three subjects did not have procedure angiography data.

Posted

Count of Participants

Participants

At time of hospital discharge

ID	Title	Description
OG000	LIFESTREAM™	This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent. Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent

Units	Counts
Participants

Secondary

Number of Devices With Acute Technical Success at Index Procedure

Acute Technical Success defined as successful deployment of the LIFESTREAM™ Covered Stent at the intended location, as determined by the Investigator.

Posted

Count of Units

Devices

At time of index procedure

Devices

ID	Title	Description
OG000	LIFESTREAM™	This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent. Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent

Units	Counts
Participants	OG000

Secondary

Number of Participants With Target Lesion Revascularization (TLR) at 6, 9, 12, 24, and 36 Months Post Index Procedure

Target Lesion Revascularization (TLR) is defined as the first revascularization procedure (e.g., PTA, atherectomy, etc.) of the target lesion(s) following the index procedure, as determined by an Independent Angiographic Core Lab. All Target Lesion Revascularizations (TLR) were Target Vessel Revascularizations (TVR) and therefore, the results presented in Outcome #6 and Outcome #7 are the same.

The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.

Posted

Number

Participants

6, 9, 12, 24, and 36 months post index procedure

ID	Title	Description
OG000	LIFESTREAM™	This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent. Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent

Units	Counts

Secondary

Number of Participants With Target Vessel Revascularization (TVR) Event at 6, 9, 12, 24, and 36 Months Post Index Procedure.

Target Vessel Revascularization (TVR) is defined as the first revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) in the target vessel(s) following the index procedure, as determined by an Independent Angiographic Core Lab. All Target Vessel Revascularizations (TVR) were Target Lesion Revascularizations (TLR) and therefore, the results presented in Outcome #6 and Outcome #7 are the same.

The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.

Posted

Number

Participants

6, 9, 12, 24, and 36 months post index procedure

ID	Title	Description
OG000	LIFESTREAM™	This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent. Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent

Units	Counts

Secondary

Number of Participants With Sustained Clinical Success at 30-Days and 9, 12, 24, and 36 Months Post Index Procedure

Sustained Clinical Success defined as sustained cumulative improvement from baseline value of ≥ 1 Rutherford Category23 at 30-days and 9, 12, 24, and 36-months post-index procedure, as determined by the Investigator.

The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.

Posted

Count of Participants

Participants

30 days, and 9, 12, 24, and 36 months post index procedure

ID	Title	Description
OG000	LIFESTREAM™	This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent. Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent

Units	Counts
Participants

Secondary

Number of Participants With Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure

Primary Patency at 9, 12, 24 and 36-months post-index procedure corresponding to PSVR ≤ 2.4.

The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.

Posted

Count of Participants

Participants

9, 12, 24 and 36 months post index procedure

ID	Title	Description
OG000	LIFESTREAM™	This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent. Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent

Units	Counts
Participants	OG000

Secondary

Number of Participants With Assisted Primary Patency at 9, 12, 24, and 36 Months Post Index Procedure

Primary Assisted Patency at 9-, 12-, 24-, and 36-months post-index procedure corresponding to PSVR ≤ 2.4, as determined by an Independent DUS Core Lab. Primary Assisted Patency is independent of whether or not patency is re-established via an endovascular procedure following restenosis.

The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.

Posted

Count of Participants

Participants

9, 12, 24, and 36 months post index procedure

ID	Title	Description
OG000	LIFESTREAM™	This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent. Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent

Units	Counts
Participants

Secondary

Number of Participants With Secondary Patency at 9, 12, 24, and 36 Months Post Index Procedure.

Secondary Patency is a measure of success at re-establishing patency following failure of the initial stent placement due to stenosis or re-occlusion. In this study, Secondary Patency was independent of whether or not patency was re-established via an endovascular procedure following restenosis or occlusion, and was analyzed for the Intent to Treat (ITT) population. Secondary patency is defined as a peak systolic velocity ratio (PSVR) ≤ 2.4, as determined by an independent Duplex Ultrasonography (DUS) Core Lab.

The number of participants analyzed (n) at each time point varies from the total of participants in the study (N) in relation to subjects censored at each time point.

Posted

Count of Participants

Participants

9,12, 24, and 36 months post index procedure

ID	Title	Description
OG000	LIFESTREAM™	This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent. Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent

Secondary

Change in Walking Impairment Questionnaire (WIQ) Scores at 30 Days, 9, 12, 24, and 36-Months Post Index Procedure Compared to Baseline.

The WIQ assesses 3 categories of activities that include 1) walking distance, 2) stair-climbing, and 3) walking speed. Each question requires participants to rate their degree of difficulty with the activity on a scale of 0 (unable) to 4 (no problem). Final scores range from 0% to 100%, with lower percentages indicating higher levels of difficulties with activities.The results below represent the mean differences in total Walking Impairment Questionnaire (WIQ) scores at 30 days,9, 12, 24, and 36 months compared to baseline assessment scores.

The number of participants (n) varies from the total number of participants (N) in the study as n depends on the number of participants for which data was available at the given time-point analysis.

Posted

Mean

Standard Deviation

Score on a scale

30 Days, 9, 12, 24, and 36 months post index procedure compared to baseline.

ID	Title	Description
OG000	LIFESTREAM™	This is a single arm study. All subjects receive percutaneous transluminal angioplasty (PTA) and implantation of the LIFESTREAM™ covered stent. Percutaneous transluminal angioplasty (PTA): Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. LIFESTREAM™ covered stent: Implantation of the LIFESTREAM™ covered stent

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (16.1)	Systematic Assessment	EG0003 affected155 at risk
Iron Deficiency Anaemia	Blood and lymphatic system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0005 affected155 at risk
Aortic Valve Stenosis	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0005 affected155 at risk
Atrioventricular Block Complete	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Bradycardia	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Cardiac Arrest	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0002 affected155 at risk
Cardiac Failure	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0002 affected155 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0004 affected155 at risk
Cardiogenic Shock	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0003 affected155 at risk
Coronary Artery Occlusion	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Pericardial Effusion	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Vestibular Disorder	Ear and labyrinth disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Cataract	Eye disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Retinal Vein Thrombosis	Eye disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Abdominal Discomfort	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Duodenal Ulcer	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Gastric Ulcer	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0003 affected155 at risk
Inguinal Hernia	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Pancreatitis Chronic	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Retroperitoneal Haemorrhage	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA (16.1)	Systematic Assessment	EG0002 affected155 at risk
Adverse Drug Reaction	General disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Chest Pain	General disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Death	General disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Device Occlusion	General disorders	MedDRA (16.1)	Systematic Assessment	EG0008 affected155 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Thrombosis In Device	General disorders	MedDRA (16.1)	Systematic Assessment	EG0002 affected155 at risk
Vessel Puncture Site Bruise	General disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Cholecystitis Chronic	Hepatobiliary disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Gallbladder Perforation	Hepatobiliary disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Bacteraemia	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Bronchopneumonia	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Cellulitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Cholecystitis Infective	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Diverticulitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0002 affected155 at risk
Gangrene	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Groin Abscess	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Haematoma Infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Kidney Infection	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Osteomyelitis	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Perirectal Abscess	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Pneumonia	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Pyelonephritis	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Scrotal Abscess	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Sepsis	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Septic Shock	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Subcutaneous Abscess	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Urosepsis	Infections and infestations	MedDRA (16.1)	Systematic Assessment	EG0003 affected155 at risk
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Laceration	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Peripheral Arterial Reocclusion	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0002 affected155 at risk
Peripheral Artery Restenosis	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0009 affected155 at risk
Pneumothorax Traumatic	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Postoperative Ileus	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Radial Nerve Injury	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Thermal Burn	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Toxicity To Various Agents	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Vascular Graft Occlusion	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Vascular Pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0003 affected155 at risk
Wound	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Wrist Fracture	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Haemoglobin Decreased	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Staphylococcus Test	Investigations	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Abnormal Loss Of Weight	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Diabetes Mellitus Inadequate Control	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Failure To Thrive	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Fluid Overload	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0002 affected155 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Compartment Syndrome	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Immune-Mediated Necrotising Myopathy	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0002 affected155 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0002 affected155 at risk
Rotator Cuff Syndrome	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0002 affected155 at risk
Spinal Column Stenosis	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Spinal Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (16.1)	Systematic Assessment	EG0002 affected155 at risk
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Brain Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Colon Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Colon Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Hepatocellular Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Lung Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Malignant Neoplasm Of Pleura	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Squamous Cell Carcinoma Of Lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Carotid Artery Occlusion	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0007 affected155 at risk
Cerebellar Ischaemia	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Cervical Myelopathy	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Dizziness	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Presyncope	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Radial Nerve Palsy	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Sciatica	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Syncope	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG0003 affected155 at risk
Psychosomatic Disease	Psychiatric disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Bladder Mass	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0002 affected155 at risk
Calculus Urinary	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0002 affected155 at risk
Renal Artery Stenosis	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Renal Failure	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0005 affected155 at risk
Urethral Stenosis	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Urinary Retention	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0003 affected155 at risk
Cervical Dysplasia	Reproductive system and breast disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Genital Prolapse	Reproductive system and breast disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0003 affected155 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Pneumonia Aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Pulmonary Hypertension	Respiratory, thoracic and mediastinal disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Incisional Drainage	Surgical and medical procedures	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Arteriovenous Fistula	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Diabetic Microangiopathy	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Hypertensive Crisis	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Iliac Artery Occlusion	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Intermittent Claudication	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Leriche Syndrome	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG00014 affected155 at risk
Peripheral Artery Dissection	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Peripheral Artery Stenosis	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG00019 affected155 at risk
Peripheral Artery Thrombosis	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0002 affected155 at risk
Peripheral Embolism	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Peripheral Ischaemia	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0002 affected155 at risk
Subclavian Artery Occlusion	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Subclavian Artery Stenosis	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk
Venous Insufficiency	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0001 affected155 at risk

ID	Term
D058729	Peripheral Arterial Disease
D016491	Peripheral Vascular Diseases
D001157	Arterial Occlusive Diseases
D050197	Atherosclerosis
D007383	Intermittent Claudication

ID	Term
D001161	Arteriosclerosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D002404	Catheterization
D013812	Therapeutics
D057510	Endovascular Procedures
D014656	Vascular Surgical Procedures
D013504	Cardiovascular Surgical Procedures
D013514	Surgical Procedures, Operative
D019060	Minimally Invasive Surgical Procedures
D008919	Investigative Techniques

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Atrial Fibrillation	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0008 affected155 at risk
Adverse Drug Reaction	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0009 affected155 at risk
Device Occlusion	General disorders	MedDRA (16.1)	Systematic Assessment	EG0008 affected155 at risk
Oedema Peripheral	General disorders	MedDRA (16.1)	Systematic Assessment	EG0008 affected155 at risk
Vessel Puncture Site Haematoma	General disorders	MedDRA (16.1)	Systematic Assessment	EG0009 affected155 at risk
Peripheral Artery Restenosis	Injury, poisoning and procedural complications	MedDRA (16.1)	Systematic Assessment	EG00017 affected155 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA (16.1)	Systematic Assessment	EG00011 affected155 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA (16.1)	Systematic Assessment	EG0009 affected155 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG00019 affected155 at risk
Peripheral Artery Dissection	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG0009 affected155 at risk
Peripheral Artery Stenosis	Vascular disorders	MedDRA (16.1)	Systematic Assessment	EG00039 affected155 at risk