Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous A... | NCT01858428

Label	Type	Description	Intervention Names
Bare PTA	Active Comparator	The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).	Device: EverCross Percutaneous Transluminal Balloon Catheter
Drug-Coated PTA	Experimental	The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.	Device: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter

Name	Type	Description	Arm Group Labels	Other Names
Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter	Device	The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.

Measure	Description	Time Frame
Patency at 12 Month Post-procedure	Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.	12 months
Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization	Freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization through 12 months post-procedure.	30 Days and 12 months

Measure	Description	Time Frame
Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure	Major adverse event (MAE) rate in the hospital and at 1, 6, 12, 24, 36, 48 and 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).	1, 6, 12, 24, 36, 48 and 60 months

Name	Affiliation	Role
Prakash Krishnan, MD	Mt. Sinai Medical Center	Principal Investigator
Sean Lyden, MD	The Cleveland Clinic	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Yuma Regional Medical Center		Yuma	Arizona	85364	United States
Mission Cardiovascular Research Institute

PubMed Identifier	Type	Citation	Retractions
39019203	Derived	Krishnan P, Faries P, Niazi K, Sachar R, Jain A, Brodmann M, Werner M, Holden A, Tarricone A, Tarra T, Lyden S. Stellarex Drug-Coated Balloon for the Treatment of Peripheral Artery Disease: Five-Year Results from the ILLUMENATE Pivotal Randomized Controlled Trial. Am J Cardiol. 2024 Sep 15;227:83-90. doi: 10.1016/j.amjcard.2024.06.027. Epub 2024 Jul 15.
34506898

ID	Title	Description
FG000	Bare PTA	EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
FG001	Drug-Coated PTA	Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.

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

Patency at 12 Month Post-procedure

Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.

Missing outcome status due to early study exit may differ from the total subjects exited by each visit interval as some subjects may have been eligible for failures carried forward or had a Clinically driven target lesion revasc (CD-TLR) prior to study exit.

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Bare PTA	EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
OG001	Drug-Coated PTA	Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.

Units	Counts
Participants	OG00092 OG001177

Title

Denominators

Categories

Title	Measurements
	OG00053 OG001135

Primary

Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization

Freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization through 12 months post-procedure.

Some Safety Status Missing at 12 Months Missing outcome status due to early study exit may differ from the total subjects exited by each visit interval as some subjects may have had a primary safety event within 12 months prior to study exit.

Posted

Count of Participants

Participants

30 Days and 12 months

ID	Title	Description
OG000	Bare PTA	EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
OG001	Drug-Coated PTA	Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.

Units	Counts
Participants

Secondary

Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure

Major adverse event (MAE) rate in the hospital and at 1, 6, 12, 24, 36, 48 and 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).

Posted

Number

Events

1, 6, 12, 24, 36, 48 and 60 months

ID	Title	Description
OG000	Bare PTA	EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
OG001	Drug-Coated PTA	Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.

Units	Counts
Participants	OG000

Secondary

Rate of Vascular Access and Bleeding Complications

Rate of vascular access and bleeding complications in the hospital and at 1, 6, 12 and 24 months.

Posted

Number

participants

in-hospital and 1, 6, 12 and 24 months

ID	Title	Description
OG000	Bare PTA	EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
OG001	Drug-Coated PTA	Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.

Units	Counts
Participants	OG000

Secondary

Rate of Clinically-driven Target Lesion Revascularization

Posted

Number

participants

6, 12, 24, 36, 48 and 60 months

ID	Title	Description
OG000	Bare PTA	EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
OG001	Drug-Coated PTA	Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.

Units	Counts
Participants	OG000

Secondary

Rate of Target Lesion Revascularization

Posted

Number

participants

6, 12, 24, 36, 48 and 60 months

ID	Title	Description
OG000	Bare PTA	EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
OG001	Drug-Coated PTA	Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.

Units	Counts
Participants	OG000

Secondary

Rate of Target Limb Major Amputation

Posted

Number

participants

1, 6, 12, 24, 36, 48 and 60 months

ID	Title	Description
OG000	Bare PTA	EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
OG001	Drug-Coated PTA	Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.

Units	Counts
Participants	OG000

Secondary

Mortality Rate

Posted

Number

participants

6, 12, 24, 36, 48 and 60 months

ID	Title	Description
OG000	Bare PTA	EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
OG001	Drug-Coated PTA	Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.

Units	Counts
Participants	OG000

Secondary

Rate of Occurrence of Arterial Thrombosis of the Treated Segment

Posted

Number

participants

1, 6, 12, 24, 36, 48 and 60 months

ID	Title	Description
OG000	Bare PTA	EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
OG001	Drug-Coated PTA	Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.

Units	Counts
Participants	OG000

Secondary

Patency Rate and Freedom From Clinically-driven TLR

Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR at 6, 24 and 36 months

Posted

Number

participants

6, 24 and 36 months

ID	Title	Description
OG000	Bare PTA	EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
OG001	Drug-Coated PTA	Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.

Units	Counts
Participants	OG000

Secondary

Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%

Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using any device after wire passage through the lesion.

Posted

Number

participants

procedure, Day 0

ID	Title	Description
OG000	Bare PTA	EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
OG001	Drug-Coated PTA	Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.

Units	Counts
Participants	OG000

Secondary

Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50%

Technical success, defined as achievement of a final in-lesion residual diameter stenosis of ≤50% (as determined by the angiographic core lab), using the CVI Paclitaxel-coated PTA Catheter or bare balloon catheter without a device malfunction after wire passage through the lesion.

Posted

Number

Lesion

procedure, Day 0

ID	Title	Description
OG000	Bare PTA	EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
OG001	Drug-Coated PTA	Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.

Units	Counts
Participants	OG000

Secondary

Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure

Clinical success (per subject) defined as technical success without the occurrence of major adverse events during the procedure.

Posted

Number

participants

procedure, Day 0

ID	Title	Description
OG000	Bare PTA	EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
OG001	Drug-Coated PTA	Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.

Units	Counts
Participants	OG000

Secondary

Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure

Procedural success (per subject) defined as lesion success without the occurrence of major adverse events during the procedure.

Posted

Count of Participants

Participants

procedure, Day 0

ID	Title	Description
OG000	Bare PTA	EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
OG001	Drug-Coated PTA	Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.

Units	Counts
Participants	OG000

Secondary

Change in Ankle-brachial Index (ABI) From Pre-procedure

Subjects who had reinterventions were included in ABI analyses so some improvements may be reflective of revascularizations during the follow-up period.

Posted

Count of Participants

Participants

6, 12, 24 and 36 months

ID	Title	Description
OG000	Bare PTA	EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
OG001	Drug-Coated PTA	Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0014 events3 affected200 at risk
Hypochromic Anaemia	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 affected100 at risk EG0014 events3 affected200 at risk
Angina Pectoris	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 events2 affected100 at risk EG0017 events5 affected200 at risk
Angina Unstable	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0012 events2 affected200 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0014 events4 affected200 at risk
Atrioventricular Block	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Cardiac Arrest	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Cardiac Failure	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0016 events2 affected200 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0014 events3 affected200 at risk
Mitral Valve Incompetence	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Myocardial Infarction	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0013 events3 affected200 at risk
Sick Sinus Syndrome	Cardiac disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected200 at risk
Hydrocele	Congenital, familial and genetic disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Hypothyroidism	Endocrine disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Blindness Unilateral	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Cataract	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Retinal Artery Occlusion	Eye disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Abdominal Hernia	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected200 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Abdominal Pain Upper	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Barrett's Oesophagus	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Colitis	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected200 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected200 at risk
Diarrhoea Haemorrhagic	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Duodenal Ulcer	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Gastrointestinal Angiodysplasia	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Gastrointestinal Angiodysplasia Haemorrhagic	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0013 events3 affected200 at risk
Intestinal Ischaemia	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected200 at risk
Melaena	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Nausea	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected200 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Catheter Site Haematoma	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Catheter Site Haemorrhage	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Chest Discomfort	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected200 at risk
Chest Pain	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0004 events4 affected100 at risk EG00112 events8 affected200 at risk
Death	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 events2 affected100 at risk EG0010 events0 affected200 at risk
Device Occlusion	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected200 at risk
Non-Cardiac Chest Pain	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected200 at risk
Sudden Cardiac Death	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Vessel Puncture Site Thrombosis	General disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Bile Duct Stenosis	Hepatobiliary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Cholangitis Acute	Hepatobiliary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Hypersensitivity	Immune system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Appendicitis Perforated	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Bacteraemia	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0013 events2 affected200 at risk
Bronchitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected200 at risk
Bronchopneumonia	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Bursitis Infective	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Cellulitis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0003 events2 affected100 at risk EG0012 events2 affected200 at risk
Diabetic Foot Infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Endocarditis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Escherichia Sepsis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0012 events1 affected200 at risk
Fungaemia	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Gastroenteritis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected200 at risk
Gastroenteritis Viral	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
H1N1 Influenza	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Pneumonia	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0003 events3 affected100 at risk EG0013 events3 affected200 at risk
Sepsis	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0013 events2 affected200 at risk
Staphylococcal Infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Urinary Tract Infection	Infections and infestations	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0015 events4 affected200 at risk
Accidental Overdose	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Anaemia Postoperative	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected200 at risk
Fall	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected200 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Hip Fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Multiple Fractures	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Peripheral Arterial Reocclusion	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Peripheral Artery Restenosis	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0008 events7 affected100 at risk EG0018 events8 affected200 at risk
Post Procedural Haematoma	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0012 events2 affected200 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Toxicity To Various Agents	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Vascular Graft Occlusion	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected200 at risk
Vascular Pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0014 events4 affected200 at risk
Wrist Fracture	Injury, poisoning and procedural complications	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected200 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected200 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0013 events3 affected200 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected200 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Cervical Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Dupuytren's Contracture	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0013 events3 affected200 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected200 at risk
Pain in Extremity	Musculoskeletal and connective tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 events2 affected100 at risk EG0016 events6 affected200 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected200 at risk
Neoplasm Prostate	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Salivary Gland Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Squamous Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0003 events2 affected100 at risk EG0011 events1 affected200 at risk
Headache	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Hydrocephalus	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Syncope	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0002 events2 affected100 at risk EG0011 events1 affected200 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Depression	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Mental Status Changes	Psychiatric disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Haematuria	Renal and urinary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0012 events1 affected200 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Renal Artery Stenosis	Renal and urinary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected200 at risk
Renal Failure	Renal and urinary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0013 events3 affected200 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0016 events6 affected200 at risk
Renal Failure Chronic	Renal and urinary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Urinary Retention	Renal and urinary disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Benign Prostatic Hyperplasia	Reproductive system and breast disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Ovarian Cyst	Reproductive system and breast disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected200 at risk
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Dermatitis Contact	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Rash Maculo-Papular	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Skin Ulcer	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Knee Arthroplasty	Surgical and medical procedures	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Obesity Surgery	Surgical and medical procedures	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Peripheral Revascularisation	Surgical and medical procedures	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Toe Amputation	Surgical and medical procedures	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Wound Drainage	Surgical and medical procedures	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Aortic Aneurysm	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0011 events1 affected200 at risk
Aortic Stenosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Femoral Artery Dissection	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0006 events6 affected100 at risk EG00117 events17 affected200 at risk
Femoral Artery Occlusion	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0012 events1 affected200 at risk
Haemorrhage	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Hypertension	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0012 events2 affected200 at risk
Hypertensive Crisis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Hypotension	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0014 events4 affected200 at risk
Intermittent Claudication	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0006 events6 affected100 at risk EG00117 events16 affected200 at risk
Ischaemia	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0013 events3 affected200 at risk
Peripheral Artery Dissection	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0010 events0 affected200 at risk
Peripheral Artery Stenosis	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG00021 events18 affected100 at risk EG00123 events22 affected200 at risk
Peripheral Embolism	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Peripheral Ischaemia	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk
Peripheral Vascular Disorder	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0001 events1 affected100 at risk EG0013 events3 affected200 at risk
Venous Insufficiency	Vascular disorders	MedDRA (Unspecified)	Systematic Assessment	EG0000 events0 affected100 at risk EG0011 events1 affected200 at risk

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016491	Peripheral Vascular Diseases

ID	Title	Description
BG000	Bare PTA	EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)
BG001	Drug-Coated PTA	Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Bare PTA	EverCross™ Balloon Catheter (PTA control device) (a product of Covidien during enrollment and now a product of Medtronic)	2	100	63	100	85	100
EG001	Drug-Coated PTA	Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter: The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter coated with paclitaxel using a proprietary carrier.	5	200	120	200	162	200