IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon... | NCT01566461

Label	Type	Description	Intervention Names
Drug-Coated Balloon (DCB)	Experimental	IN.PACT Admiral: Balloon Angioplasty	Device: Drug-Coated Balloon (DCB)
Standard PTA	Active Comparator	Standard Percutaneous Balloon Angioplasty (PTA) Balloon: Balloon Angioplasty	Device: PTA Balloon: Balloon Angioplasty

Name	Type	Description	Arm Group Labels	Other Names
Drug-Coated Balloon (DCB)	Device	Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm	Drug-Coated Balloon (DCB)

Measure	Description	Time Frame
Primary Patency	Primary patency is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤2.4.	12 month
Primary Safety Composite	Primary safety composite is defined as freedom from death through 30 days or target limb major amputation or clinically-driven target vessel revascularization (CD-TVR) within 12 months post index procedure.	12 month

Measure	Description	Time Frame
Major Adverse Event (MAE) Composite	Major Adverse Event (MAE) composite is defined as all cause death, clinically-driven target vessel revascularization, major target limb amputation, thrombosis at the target lesion site.	12 month
All-cause Death

Facility	Status	City	State	ZIP	Country	Contacts
Washington Hospital		Fremont	California	94538	United States
Kaiser Permanente Hawaii

PubMed Identifier	Type	Citation	Retractions
36137674	Derived	Krishnan P, Farhan S, Schneider P, Kamran H, Iida O, Brodmann M, Micari A, Sachar R, Urasawa K, Scheinert D, Ando K, Tarricone A, Doros G, Tepe G, Yokoi H, Laird J, Zeller T. Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention. J Am Coll Cardiol. 2022 Sep 27;80(13):1241-1250. doi: 10.1016/j.jacc.2022.06.043.
31543165

ID	Title	Description
FG000	Drug-Coated Balloon (DCB)	Paclitaxel drug-coated angioplasty balloon IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm
FG001	Standard PTA

ID	Title	Description
BG000	Drug-Coated Balloon (DCB)	Paclitaxel drug-coated angioplasty balloon IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm
BG001	Standard PTA	Standard angioplasty balloon without Paclitaxel drug-coating Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000220 BG001111 BG002331

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

Primary Patency

Primary patency is defined as freedom from clinically-driven target lesion revascularisation (CD-TLR) or restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤2.4.

Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.

Posted

Number

Percentage of participants

12 month

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Units	Counts
Participants	OG000191 OG001103

Title

Denominators

Categories

Title	Measurements
	OG00082.2 OG00152.4

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 OG001		z-test		<0.001						2-Sided								Superiority or Other

Primary

Primary Safety Composite

Primary safety composite is defined as freedom from death through 30 days or target limb major amputation or clinically-driven target vessel revascularization (CD-TVR) within 12 months post index procedure.

Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.

Posted

Number

Percentage of particpants

12 month

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Units	Counts
Participants	OG000

Secondary

Major Adverse Event (MAE) Composite

Major Adverse Event (MAE) composite is defined as all cause death, clinically-driven target vessel revascularization, major target limb amputation, thrombosis at the target lesion site.

Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.

Posted

Number

Percentage of participants

12 month

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Units	Counts
Participants	OG000

Secondary

All-cause Death

Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.

Posted

Number

Percentage of participants

12 month

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Units	Counts
Participants	OG000

Secondary

Target Vessel Revascularization (TVR)

Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.

Posted

Number

Percentage of participants

12 month

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Units	Counts
Participants	OG000

Secondary

Target Lesion Revascularization (TLR)

Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.

Posted

Number

Percentage of participants

12 month

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Units	Counts
Participants	OG000

Secondary

Time to First Clinically Driven Target Lesion Revascularization (CD-TLR)

Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention within the target lesion due to symptoms or drop of ankle brachial index (ABI) of ≥20% or >0.15 when compared to post procedure baseline.

Includes all subjects who experienced a CD-TLR.

Posted

Mean

Standard Deviation

Days

12 month

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Units	Counts
Participants	OG000

Secondary

Major Target Limb Amputation

Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.

Posted

Number

Percentage of participants

12 month

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Units	Counts
Participants	OG000

Secondary

Thrombosis at the Target Lesion

Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.

Posted

Number

Percentage of participants

12 month

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Units	Counts
Participants	OG000

Secondary

Primary Sustained Clinical Improvement

Freedom from target limb amputation, target vessel revascularization (TVR), and increase in Rutherford class.

Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.

Posted

Number

Percentage of participants

12 month

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Units	Counts
Participants	OG000

Secondary

Secondary Sustained Clinical Improvement

Freedom from target amputation and increase in Rutherford class.

Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.

Posted

Number

Percentage of particpants

12 month

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Units	Counts
Participants	OG000

Secondary

Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >2.4)

Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.

Posted

Number

Percentage of participants

12 month

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Units	Counts
Participants	OG000

Secondary

Duplex-defined Binary Restenosis (Peak Systolic Velocity Ratio (PSVR) >3.4)

Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.

Posted

Number

Percentage of participants

12 month

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Units	Counts
Participants	OG000

Secondary

Quality of Life Assessment by EuroQol Group 5-Dimension Self-Report Questionnaire (EQ5D)

Quality of life assessment by EQ5D at 1 year compared to baseline. EQ5D is a standardised measure of health status and economic appraisal. The EQ5D consists of the EQ5D descriptive system which comprises the following variables for the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: (1) no problems, (2) some problems, (3) extreme problems. A complex algorithm that took individual dimensions and generated an overall score was used.

EQ5D health state is used in the algorithm to calculate an overall score where - 0.109 = 'worst possible outcome' and 1.000 = 'best possible outcome'.

Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.

Posted

Mean

Standard Deviation

Units on a scale

12 month

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Secondary

Change in Walking Distance as Assessed by Six Minute Walk Test (6MWT)

Change from baseline in walking distance by Six Minute Walk Test (6MWT) at 12 month.

Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe. Data not collected in IN.PACT SFA I phase.

Posted

Mean

Standard Deviation

Meters

From baseline to 12 month

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Units	Counts
Participants	OG000

Secondary

Walking Capacity Assessment by Walking Impairment Questionnaire (WIQ)

Walking capacity assessment by WIQ at 1 year compared to baseline. WIQ is a quality of life questionnaire that was specifically designed to assess the degree of impairment experienced by patients with claudication.

Clinical outcomes were assessed by patients responses to question 1A. Question 1A is specific for calf or buttocks claudication and is used to create a summary score for analysis. Question 1A is expressed on a scale of 0% (unable to perform because of severe claudication) to 100% (no impairment).

Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.

Posted

Mean

Standard Deviation

Units on a scale

12 month

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Secondary

Device Success

Device success is defined as successful delivery, balloon inflation and deflation and retrieval of the intact study device without burst below rated burst pressure (RBP).

Total number of devices used in the ITT population (n=331).

Posted

Number

Percentage of devices

Day 1

Devices

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Units	Counts
Participants	OG000

Secondary

Procedural Success

Procedural success is defined as residual stenosis of ≤50% (non-stented subjects) or ≤30% (stented subjects) by core lab assessment.

Intention-to-Treat (n=331)

Posted

Number

Percentage of participants

Day 1

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Units	Counts
Participants	OG000

Secondary

Clinical Success

Clinical success is defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or Target vessel revascularization (TVR)) prior to discharge.

Intention-to-Treat (n=331)

Posted

Number

Percentage of participants

Day 1

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Units	Counts
Participants	OG000

Secondary

Days of Hospitalization Due to the Index Lesion

Days of hospitalization from procedure through 12 month.

Intention-to-Treat population (n=331) that excludes subjects who did not have evaluable data at the reporting timeframe.

Posted

Mean

Standard Deviation

Days

12 month

ID	Title	Description
OG000	Drug-Coated Balloon (DCB)	IN.PACT Admiral: Balloon Angioplasty IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
OG001	Standard PTA	Standard PTA Balloon: Balloon Angioplasty Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Statistical Information
Abdominal Pain	Gastrointestinal disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Acute Coronary Syndrome	Cardiac disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA 13.0	EG0003 events3 affected220 at risk EG0010 events0 affected111 at risk
Acute Pulmonary Oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Adverse Drug Reaction	General disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Amnesia	Nervous system disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 13.0	EG0004 events4 affected220 at risk EG0011 events1 affected111 at risk
MedDRA 13.0	Gastrointestinal disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Angina Pectoris	Cardiac disorders	MedDRA 13.0	EG0002 events2 affected220 at risk EG0011 events1 affected111 at risk
Angina Unstable	Cardiac disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Aorto-Duodenal Fistula	Vascular disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0010 events0 affected111 at risk
Arrhythmia	Cardiac disorders	MedDRA 13.0	EG0002 events1 affected220 at risk EG0010 events0 affected111 at risk
Arterial Occlusive Disease	Vascular disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Arterial Restenosis	Injury, poisoning and procedural complications	MedDRA 13.0	EG0001 events1 affected220 at risk EG0014 events4 affected111 at risk
Arterial Stenosis Limb	Vascular disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0013 events3 affected111 at risk
Arterial Thrombosis Limb	Vascular disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0010 events0 affected111 at risk
Arteriovenous Fistula	Vascular disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0012 events2 affected111 at risk
Artery Dissection	Vascular disorders	MedDRA 13.0	EG0008 events7 affected220 at risk EG0012 events2 affected111 at risk
Arthritis Bacterial	Infections and infestations	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 13.0	EG0002 events2 affected220 at risk EG0012 events2 affected111 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0011 events1 affected111 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Bile Duct Obstruction	Hepatobiliary disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Biliary Sepsis	Infections and infestations	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Bronchiectasis	Infections and infestations	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA 13.0	EG0006 events6 affected220 at risk EG0011 events1 affected111 at risk
Carotid Artery Disease	Nervous system disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Carotid Artery Stenosis	Nervous system disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0012 events2 affected111 at risk
Cellulitis	Infections and infestations	MedDRA 13.0	EG0000 events0 affected220 at risk EG0010 events0 affected111 at risk
Cerebral Infarction	Nervous system disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0011 events1 affected111 at risk
Cerebrovascular Accident	Nervous system disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Chest Pain	General disorders	MedDRA 13.0	EG0002 events2 affected220 at risk EG0011 events1 affected111 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Colon Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA 13.0	EG0007 events7 affected220 at risk EG0011 events1 affected111 at risk
Coronary Artery Thrombosis	Cardiac disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Device Occlusion	General disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0011 events1 affected111 at risk
Device Related Infection	Infections and infestations	MedDRA 13.0	EG0000 events0 affected220 at risk EG0010 events0 affected111 at risk
Diabetic Foot	Metabolism and nutrition disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0010 events0 affected111 at risk
Diabetic Retinopathy	Eye disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Dry Gangrene	Skin and subcutaneous tissue disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Dyspnoea Exertional	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Embolic Cerebral Infarction	Nervous system disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Facial Bones Fracture	Injury, poisoning and procedural complications	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Femoral Arterial Stenosis	Vascular disorders	MedDRA 13.0	EG00018 events15 affected220 at risk EG00112 events10 affected111 at risk
Femoral Artery Dissection	Vascular disorders	MedDRA 13.0	EG0004 events4 affected220 at risk EG0015 events5 affected111 at risk
Femoral Artery Occlusion	Vascular disorders	MedDRA 13.0	EG0005 events3 affected220 at risk EG0015 events5 affected111 at risk
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA 13.0	EG0001 events1 affected220 at risk EG0011 events1 affected111 at risk
Fibula Fracture	Injury, poisoning and procedural complications	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Fractured Coccyx	Injury, poisoning and procedural complications	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Gangrene	Infections and infestations	MedDRA 13.0	EG0002 events2 affected220 at risk EG0010 events0 affected111 at risk
Gastroenteritis	Infections and infestations	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 13.0	EG0002 events2 affected220 at risk EG0011 events1 affected111 at risk
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Haematoma	Vascular disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Haematuria	Renal and urinary disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Haemorrhage	Vascular disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Haemorrhage Intracranial	Nervous system disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Haemorrhagic Anaemia	Blood and lymphatic system disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Hepatic Cirrhosis	Hepatobiliary disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Hypotension	Vascular disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Iliac Artery Occlusion	Vascular disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0010 events0 affected111 at risk
Iliac Artery Stenosis	Vascular disorders	MedDRA 13.0	EG0002 events2 affected220 at risk EG0011 events1 affected111 at risk
Impaired Gastric Emptying	Gastrointestinal disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Impaired Healing	General disorders	MedDRA 13.0	EG0002 events1 affected220 at risk EG0011 events1 affected111 at risk
Implant Site Thrombosis	General disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
In-Stent Arterial Restenosis	Injury, poisoning and procedural complications	MedDRA 13.0	EG0003 events3 affected220 at risk EG0011 events1 affected111 at risk
In-Stent Coronary Artery Restenosis	Injury, poisoning and procedural complications	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Infected Lymphocele	Infections and infestations	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Intermittent Claudication	Vascular disorders	MedDRA 13.0	EG0007 events7 affected220 at risk EG00112 events11 affected111 at risk
Intervertebral Disc Protrusion	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Intestinal Obstruction	Gastrointestinal disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Joint Surgery	Surgical and medical procedures	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Large Intestine Perforation	Gastrointestinal disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Lipoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Liver Disorder	Hepatobiliary disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Localised Infection	Infections and infestations	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Lumbar Radiculopathy	Nervous system disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Lumbar Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0002 events2 affected220 at risk EG0011 events1 affected111 at risk
Lumbar Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	EG0000 events0 affected220 at risk EG0010 events0 affected111 at risk
Mass	General disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Melaena	Gastrointestinal disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Mental Status Changes	Psychiatric disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0010 events0 affected111 at risk
Multi-Organ Failure	General disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Myocardial Infarction	Cardiac disorders	MedDRA 13.0	EG0002 events2 affected220 at risk EG0011 events1 affected111 at risk
Myocardial Ischaemia	Cardiac disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Necrosis	General disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Neuropathic Ulcer	Skin and subcutaneous tissue disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Obesity	Metabolism and nutrition disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Oedema Peripheral	General disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Orthostatic Hypotension	Vascular disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0011 events1 affected111 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0002 events2 affected220 at risk EG0010 events0 affected111 at risk
Osteomyelitis	Infections and infestations	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA 13.0	EG0000 events0 affected220 at risk EG0010 events0 affected111 at risk
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0002 events2 affected220 at risk EG0011 events1 affected111 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 13.0	EG0002 events1 affected220 at risk EG0010 events0 affected111 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Paraesthesia	Nervous system disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Peptic Ulcer	Gastrointestinal disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0010 events0 affected111 at risk
Peripheral Arterial Occlusive Disease	Vascular disorders	MedDRA 13.0	EG0008 events8 affected220 at risk EG0015 events5 affected111 at risk
Peripheral Arterial Reocclusion	Injury, poisoning and procedural complications	MedDRA 13.0	EG0000 events0 affected220 at risk EG0014 events4 affected111 at risk
Peripheral Artery Dissection	Vascular disorders	MedDRA 13.0	EG0003 events3 affected220 at risk EG0015 events4 affected111 at risk
Peripheral Embolism	Vascular disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0011 events1 affected111 at risk
Peripheral Ischaemia	Vascular disorders	MedDRA 13.0	EG0004 events2 affected220 at risk EG0012 events2 affected111 at risk
Peripheral Revascularisation	Surgical and medical procedures	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Peripheral Vascular Disorder	Vascular disorders	MedDRA 13.0	EG0002 events2 affected220 at risk EG0010 events0 affected111 at risk
Peritonitis	Gastrointestinal disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Pneumonia	Infections and infestations	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Polyp	General disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Postmenopausal Haemorrhage	Reproductive system and breast disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Prostate Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Prostatic Specific Antigen Increased	Investigations	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Renal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Renal Colic	Renal and urinary disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Renal Failure	Renal and urinary disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0011 events1 affected111 at risk
Sepsis	Infections and infestations	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Shock Haemorrhagic	Vascular disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Sinus Tachycardia	Cardiac disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Spinal Column Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Spinal Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Spondylolisthesis	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Subclavian Artery Stenosis	Vascular disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Sudden Death	General disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Supraventricular Tachycardia	Cardiac disorders	MedDRA 13.0	EG0000 events0 affected220 at risk EG0011 events1 affected111 at risk
Syncope	Nervous system disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0012 events2 affected111 at risk
Synovial Cyst	Musculoskeletal and connective tissue disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Therapeutic Embolisation	Surgical and medical procedures	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Tonsil Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA 13.0	EG0003 events3 affected220 at risk EG0010 events0 affected111 at risk
Urinary Tract Infection	Infections and infestations	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Vascular Graft Occlusion	Injury, poisoning and procedural complications	MedDRA 13.0	EG0002 events1 affected220 at risk EG0010 events0 affected111 at risk
Vascular Pseudoaneurysm	Injury, poisoning and procedural complications	MedDRA 13.0	EG0003 events3 affected220 at risk EG0013 events3 affected111 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 at risk
Vessel Puncture Site Haematoma	General disorders	MedDRA 13.0	EG0002 events2 affected220 at risk EG0010 events0 affected111 at risk
West Nile Viral Infection	Infections and infestations	MedDRA 13.0	EG0001 events1 affected220 at risk EG0010 events0 affected111 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	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Drug-Coated Balloon (DCB)	Paclitaxel drug-coated angioplasty balloon IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm			102	220	104	220
EG001	Standard PTA	Standard angioplasty balloon without Paclitaxel drug-coating Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm			62	111	62	111