Trial Outcomes & Findings for A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries. (NCT NCT02080871)

NCT ID: NCT02080871

Last Updated: 2019-01-16

Results Overview

Percentage of study subjects experiencing a major adverse event (MAE) defined as: device or procedure-related death within 30 days, myocardial infarction (MI) within 30 days, target lesion revascularization (TLR) within 9 months or major amputation of the target limb within 9 months.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 134 participants
• Primary outcome timeframe: 9 months
• Results posted on: 2019-01-16

Participant Flow

Participant milestones

Measure	Gore VIABAHN BX Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Overall Study STARTED	134
Overall Study COMPLETED	132
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Gore VIABAHN BX Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Overall Study Death	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

A Study of the Gore VIABAHN BX for Treatment of Occlusive Disease in the Iliac Arteries.

Baseline characteristics by cohort

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Age, Continuous	66 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	79 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	128 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	122 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment New Zealand	27 Participants n=5 Participants
Region of Enrollment United States	107 Participants n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Population: Population includes enrolled subjects who either experienced the defined event or were followed for at least 240 days.

Percentage of study subjects experiencing a major adverse event (MAE) defined as: device or procedure-related death within 30 days, myocardial infarction (MI) within 30 days, target lesion revascularization (TLR) within 9 months or major amputation of the target limb within 9 months.

Outcome measures

Measure	Iliac Stenting n=132 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Composite of Major Adverse Events (MAEs)	2.3 percentage of subjects experiencing MAE Interval 0.5 to 6.5

SECONDARY outcome

Timeframe: Discharge

Population: Population includes subjects followed through discharge and had relevant procedural data.

Number of subjects who experienced Acute Procedural Success defined as less than or equal to 30% residual stenosis prior to procedure completion and no device- or procedure-related SAEs before discharge.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Acute Procedural Success	130 Participants

SECONDARY outcome

Timeframe: 30 Days

Population: Population includes subjects followed for at least 30 days and had relevant data.

Number of subjects who experienced 30-Day Clinical Success defined as an improvement of at least one Rutherford Category at the 30-day visit as compared to pre-procedure and no device- or procedure-related SAEs within 30 days of the index procedure.

Outcome measures

Measure	Iliac Stenting n=119 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
30-Day Clinical Success	108 Participants

SECONDARY outcome

Timeframe: 30 Days

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of primary patency at 30 days.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Primary Patency	99.2 survival percentage by subject Interval 94.8 to 99.9

SECONDARY outcome

Timeframe: 9 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of primary patency at 9 months.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Primary Patency	96.7 survival percentage by subject Interval 91.5 to 98.8

SECONDARY outcome

Timeframe: 30 Days

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of primary assisted patency at 30 days.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Primary Assisted Patency	99.2 survival percentage by subject Interval 94.8 to 99.9

SECONDARY outcome

Timeframe: 9 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of primary assisted patency at 9 months.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Primary Assisted Patency	99.2 survival percentage by subject Interval 94.8 to 99.9

SECONDARY outcome

Timeframe: 30 Days

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of secondary patency at 30 days.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Secondary Patency	99.2 survival percentage by subject Interval 94.8 to 99.99

SECONDARY outcome

Timeframe: 9 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of secondary patency at 9 months.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Secondary Patency	99.2 survival percentage by subject Interval 94.8 to 99.9

SECONDARY outcome

Timeframe: 30 Days

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)	100 Percentage of participants Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: 9 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 9 months.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)	97.7 Percentage of participants Interval 92.9 to 99.2

SECONDARY outcome

Timeframe: 30 Days

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 30 days.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)	100 Percentage of participants Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: 9 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 9 months.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)	98.4 Percentage of participants Interval 93.8 to 99.6

SECONDARY outcome

Timeframe: 30 Days

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)	100 Percentage of participants Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: 9 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 9 months.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)	97.7 Percentage of participants Interval 92.9 to 99.2

SECONDARY outcome

Timeframe: 30 Days

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 30 days.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)	100 Percentage of participants Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: 9 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 9 months

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)	97.7 Percentage of participants Interval 92.9 to 99.2

SECONDARY outcome

Timeframe: 30 Days

Population: Population includes subjects followed for at least 23 days and had relevant data.

Number of participants with change in Rutherford Category from pre-procedure at 30 days.

Rutherford Categories:

Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

Outcome measures

Measure	Iliac Stenting n=118 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Rutherford Category Improved Rutherford Category	111 Participants
Number of Participants With Change in Rutherford Category Maintained Rutherford Category	6 Participants
Number of Participants With Change in Rutherford Category Worsened Rutherford Category	1 Participants

SECONDARY outcome

Timeframe: 9 Months

Population: Population includes subjects followed for at least 240 days and relevant data.

Number of participants with change in Rutherford Category from pre-procedure at 9 months.

Rutherford Categories:

Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

Outcome measures

Measure	Iliac Stenting n=112 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Rutherford Category Improved Rutherford Category	106 Participants
Number of Participants With Change in Rutherford Category Maintained Rutherford Category	6 Participants
Number of Participants With Change in Rutherford Category Worsened Rutherford Category	0 Participants

SECONDARY outcome

Timeframe: 30 Days

Population: Population includes subjects followed for at least 23 days and had relevant data.

Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.

Outcome measures

Measure	Iliac Stenting n=174 limbs Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Change in Ankle Brachial Index (ABI)	.97 ratio index Interval 0.42 to 1.34

SECONDARY outcome

Timeframe: 9 Months

Population: Population includes subjects followed for at least 240 days and had relevant data.

Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.

Outcome measures

Measure	Iliac Stenting n=169 limbs Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Change in Ankle Brachial Index (ABI)	0.97 ratio index Interval 0.42 to 1.43

SECONDARY outcome

Timeframe: 30 Days

Population: Population includes subjects followed for at least 23 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Mobility) from pre-procedure at 30 days.

Outcome measures

Measure	Iliac Stenting n=115 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Mobility Improved	51 Participants
Number of Participants With Change in Functional Status - EQ5D - Mobility Maintained	57 Participants
Number of Participants With Change in Functional Status - EQ5D - Mobility Worsened	7 Participants

SECONDARY outcome

Timeframe: 9 Months

Population: Population includes subjects followed for at least 240 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 9 months.

Outcome measures

Measure	Iliac Stenting n=114 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Mobility Improved	48 Participants
Number of Participants With Change in Functional Status - EQ5D - Mobility Maintained	62 Participants
Number of Participants With Change in Functional Status - EQ5D - Mobility Worsened	4 Participants

SECONDARY outcome

Timeframe: 30 Days

Population: Population includes subjects followed for at least 30 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Self Care) from pre-procedure at 30 days.

Outcome measures

Measure	Iliac Stenting n=115 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Self Care Improved	5 Participants
Number of Participants With Change in Functional Status - EQ5D - Self Care Maintained	108 Participants
Number of Participants With Change in Functional Status - EQ5D - Self Care Worsened	2 Participants

SECONDARY outcome

Timeframe: 9 Months

Population: Population includes subjects followed for at least 240 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 9 months.

Outcome measures

Measure	Iliac Stenting n=114 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Self Care Improved	6 Participants
Number of Participants With Change in Functional Status - EQ5D - Self Care Maintained	105 Participants
Number of Participants With Change in Functional Status - EQ5D - Self Care Worsened	3 Participants

SECONDARY outcome

Timeframe: 30 Days

Population: Population includes subjects followed for at least 30 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days.

Outcome measures

Measure	Iliac Stenting n=115 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Usual Activities Improved	52 Participants
Number of Participants With Change in Functional Status - EQ5D - Usual Activities Maintained	55 Participants
Number of Participants With Change in Functional Status - EQ5D - Usual Activities Worsened	8 Participants

SECONDARY outcome

Timeframe: 9 Months

Population: Population includes subjects followed for at least 240 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 9 months.

Outcome measures

Measure	Iliac Stenting n=114 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Usual Activities Improved	53 Participants
Number of Participants With Change in Functional Status - EQ5D - Usual Activities Maintained	57 Participants
Number of Participants With Change in Functional Status - EQ5D - Usual Activities Worsened	4 Participants

SECONDARY outcome

Timeframe: 30 Days

Population: Population includes subjects followed for at least 30 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days.

Outcome measures

Measure	Iliac Stenting n=115 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort Improved	56 Participants
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort Maintained	49 Participants
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort Worsened	10 Participants

SECONDARY outcome

Timeframe: 9 Months

Population: Population includes subjects followed for at least 240 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 9 months.

Outcome measures

Measure	Iliac Stenting n=114 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort Improved	49 Participants
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort Maintained	55 Participants
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort Worsened	10 Participants

SECONDARY outcome

Timeframe: 30 Days

Population: Population includes subjects followed for at least 30 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days.

Outcome measures

Measure	Iliac Stenting n=115 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression Improved	27 Participants
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression Maintained	82 Participants
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression Worsened	6 Participants

SECONDARY outcome

Timeframe: 9 Months

Population: Population includes subjects followed for at least 240 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 9 months.

Outcome measures

Measure	Iliac Stenting n=114 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression Improved	28 Participants
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression Maintained	79 Participants
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression Worsened	7 Participants

SECONDARY outcome

Timeframe: 30 Days

Population: Population includes subjects followed for at least 30 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 30 days.

Outcome measures

Measure	Iliac Stenting n=114 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Own Health State Improved	22 Participants
Number of Participants With Change in Functional Status - EQ5D - Own Health State Maintained	84 Participants
Number of Participants With Change in Functional Status - EQ5D - Own Health State Worsened	8 Participants

SECONDARY outcome

Timeframe: 9 Months

Population: Population includes subjects followed for at least 240 days and had relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 9 months.

Outcome measures

Measure	Iliac Stenting n=113 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Own Health State Improved	23 Participants
Number of Participants With Change in Functional Status - EQ5D - Own Health State Maintained	73 Participants
Number of Participants With Change in Functional Status - EQ5D - Own Health State Worsened	17 Participants

SECONDARY outcome

Timeframe: 30 Days

Population: Population includes subjects followed for at least 30 days and had relevant data.

Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.

Outcome measures

Measure	Iliac Stenting n=115 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Improvement in Functional Status at 30 Days - Walking Improvement Questionnaire (WIQ)	106 Participants

SECONDARY outcome

Timeframe: 9 Months

Population: Population includes subjects followed for at least 240 days and had relevant data.

Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 9 months.

Outcome measures

Measure	Iliac Stenting n=114 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Improvement in Functional Status 9 Months - Walking Improvement Questionnaire (WIQ)	102 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of primary patency at 12 months.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Primary Patency	94.4 survival percentage by subject Interval 88.7 to 97.3

SECONDARY outcome

Timeframe: 12 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of primary assisted patency at 12 months.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Primary Assisted Patency	98.4 survival percentage by subject Interval 93.9 to 99.6

SECONDARY outcome

Timeframe: 12 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of secondary patency at 12 months.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Secondary Patency	99.2 survival percentage by subject Interval 94.8 to 99.6

SECONDARY outcome

Timeframe: 12 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 12 months.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)	95.4 Percentage of participants Interval 90.1 to 97.9

SECONDARY outcome

Timeframe: 24 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 24 months.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)	93.1 Percentage of participants Interval 87.1 to 96.3

SECONDARY outcome

Timeframe: 36 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 36 months.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)	91.4 Percentage of participants Interval 84.9 to 95.1

SECONDARY outcome

Timeframe: 12 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 12 months.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)	97.7 Percentage of participants Interval 93.1 to 99.3

SECONDARY outcome

Timeframe: 24 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 24 months.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)	97.7 Percentage of participants Interval 93.1 to 99.3

SECONDARY outcome

Timeframe: 36 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 36 months.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)	97.7 Percentage of participants Interval 93.1 to 99.3

SECONDARY outcome

Timeframe: 12 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 12 months.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)	95.4 Percentage of participants Interval 90.1 to 97.9

SECONDARY outcome

Timeframe: 24 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 24 months.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)	92.3 Percentage of participants Interval 86.1 to 95.8

SECONDARY outcome

Timeframe: 36 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 36 months.

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)	90.6 Percentage of participants Interval 84.0 to 94.5

SECONDARY outcome

Timeframe: 12 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 12 months

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)	97.7 Percentage of participants Interval 93.1 to 99.3

SECONDARY outcome

Timeframe: 24 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 24 months

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)	96.9 Percentage of participants Interval 92.0 to 98.8

SECONDARY outcome

Timeframe: 36 Months

Population: Population includes all subjects meeting eligibility.

Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 36 months

Outcome measures

Measure	Iliac Stenting n=134 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)	96.1 Percentage of participants Interval 90.9 to 98.4

SECONDARY outcome

Timeframe: 12 Months

Population: Population includes subjects available at 12 Months with relevant data.

Number of participants with change in Rutherford Category from pre-procedure at 12 months.

Rutherford Categories:

Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

Outcome measures

Measure	Iliac Stenting n=114 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Rutherford Category Improved Rutherford Category	108 Participants
Number of Participants With Change in Rutherford Category Maintained Rutherford Category	6 Participants
Number of Participants With Change in Rutherford Category Worsened Rutherford Category	0 Participants

SECONDARY outcome

Timeframe: 24 Months

Population: Population includes subjects available at 24 Months with relevant data.

Number of participants with change in Rutherford Category from pre-procedure at 24 months.

Rutherford Categories:

Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

Outcome measures

Measure	Iliac Stenting n=102 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Rutherford Category Improved Rutherford Category	96 Participants
Number of Participants With Change in Rutherford Category Maintained Rutherford Category	5 Participants
Number of Participants With Change in Rutherford Category Worsened Rutherford Category	1 Participants

SECONDARY outcome

Timeframe: 36 Months

Population: Population includes subjects available at 36 Months with relevant data.

Number of participants with change in Rutherford Category from pre-procedure at 36 months.

Rutherford Categories:

Stage 0 - Asymptomatic Stage 1 - Mild claudication Stage 2 - Moderate claudication - The distance that delineates mild, moderate and severe claudication is not specified in the Rutherford classification, but is mentioned in the Fontaine classification as 200 meters.

Stage 3 - Severe claudication Stage 4 - Rest pain Stage 5 - Ischemic ulceration not exceeding ulcer of the digits of the foot Stage 6 - Severe ischemic ulcers or frank gangrene

Outcome measures

Measure	Iliac Stenting n=89 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Rutherford Category Improved Rutherford Category	82 Participants
Number of Participants With Change in Rutherford Category Maintained Rutherford Category	7 Participants
Number of Participants With Change in Rutherford Category Worsened Rutherford Category	0 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: Population includes subjects available at 12 Months with relevant data.

Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.

Outcome measures

Measure	Iliac Stenting n=165 Limbs Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Change in Ankle Brachial Index (ABI)	0.19 ratio index Interval -0.9 to 0.82

SECONDARY outcome

Timeframe: 24 Months

Population: Population includes subjects available at 24 Months with relevant data.

Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.

Outcome measures

Measure	Iliac Stenting n=148 Limbs Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Change in Ankle Brachial Index (ABI)	.17 ratio index Interval -1.0 to 0.79

SECONDARY outcome

Timeframe: 36 Months

Population: Population includes subjects available at 36 Months with relevant data.

Ankle brachial Index (ABI) is a common assessment of peripheral artery disease (PAD) and is obtained by comparing the systolic blood pressure of the legs to the systolic blood pressure of the arms. A normal resting ABI is .9 to 1.3. A resting ABI of less than .9 is abnormal. An outcome of a mean ABI above .9 and below 1.3 is considered a success.

Outcome measures

Measure	Iliac Stenting n=123 Limbs Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Change in Ankle Brachial Index (ABI)	0.17 ratio index Interval -0.4 to 0.75

SECONDARY outcome

Timeframe: 12 Months

Population: Population includes subjects available at 12 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 12 months.

Outcome measures

Measure	Iliac Stenting n=115 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Mobility Improved	44 Participants
Number of Participants With Change in Functional Status - EQ5D - Mobility Maintained	66 Participants
Number of Participants With Change in Functional Status - EQ5D - Mobility Worsened	5 Participants

SECONDARY outcome

Timeframe: 24 Months

Population: Population includes subjects available at 24 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 24 months.

Outcome measures

Measure	Iliac Stenting n=103 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Mobility Improved	45 Participants
Number of Participants With Change in Functional Status - EQ5D - Mobility Maintained	53 Participants
Number of Participants With Change in Functional Status - EQ5D - Mobility Worsened	5 Participants

SECONDARY outcome

Timeframe: 36 Months

Population: Population includes subjects available at 36 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Mobility) from pre-procedure at 36 months.

Outcome measures

Measure	Iliac Stenting n=90 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Mobility Improved	43 Participants
Number of Participants With Change in Functional Status - EQ5D - Mobility Maintained	43 Participants
Number of Participants With Change in Functional Status - EQ5D - Mobility Worsened	4 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: Population includes subjects available at 12 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 12 months.

Outcome measures

Measure	Iliac Stenting n=115 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Self Care Improved	6 Participants
Number of Participants With Change in Functional Status - EQ5D - Self Care Maintained	106 Participants
Number of Participants With Change in Functional Status - EQ5D - Self Care Worsened	3 Participants

SECONDARY outcome

Timeframe: 24 Months

Population: Population includes subjects available at 24 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 24 months.

Outcome measures

Measure	Iliac Stenting n=103 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Self Care Improved	5 Participants
Number of Participants With Change in Functional Status - EQ5D - Self Care Maintained	93 Participants
Number of Participants With Change in Functional Status - EQ5D - Self Care Worsened	5 Participants

SECONDARY outcome

Timeframe: 36 Months

Population: Population includes subjects available at 36 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in Functional Status (EQ5D - Self Care) from pre-procedure at 36 months.

Outcome measures

Measure	Iliac Stenting n=90 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Self Care Improved	4 Participants
Number of Participants With Change in Functional Status - EQ5D - Self Care Maintained	84 Participants
Number of Participants With Change in Functional Status - EQ5D - Self Care Worsened	2 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: Population includes subjects available at 12 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 12 months.

Outcome measures

Measure	Iliac Stenting n=115 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Usual Activities Improved	51 Participants
Number of Participants With Change in Functional Status - EQ5D - Usual Activities Maintained	55 Participants
Number of Participants With Change in Functional Status - EQ5D - Usual Activities Worsened	9 Participants

SECONDARY outcome

Timeframe: 24 Months

Population: Population includes subjects available at 24 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 24 months.

Outcome measures

Measure	Iliac Stenting n=103 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Usual Activities Improved	44 Participants
Number of Participants With Change in Functional Status - EQ5D - Usual Activities Maintained	51 Participants
Number of Participants With Change in Functional Status - EQ5D - Usual Activities Worsened	8 Participants

SECONDARY outcome

Timeframe: 36 Months

Population: Population includes subjects available at 36 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 36 months.

Outcome measures

Measure	Iliac Stenting n=90 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Usual Activities Improved	44 Participants
Number of Participants With Change in Functional Status - EQ5D - Usual Activities Maintained	42 Participants
Number of Participants With Change in Functional Status - EQ5D - Usual Activities Worsened	4 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: Population includes subjects available at 12 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 12 months.

Outcome measures

Measure	Iliac Stenting n=115 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort Improved	59 Participants
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort Maintained	44 Participants
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort Worsened	12 Participants

SECONDARY outcome

Timeframe: 24 Months

Population: Population includes subjects available at 24 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 24 months.

Outcome measures

Measure	Iliac Stenting n=103 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort Improved	49 Participants
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort Maintained	41 Participants
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort Worsened	13 Participants

SECONDARY outcome

Timeframe: 36 Months

Population: Population includes subjects available at 36 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 36 months.

Outcome measures

Measure	Iliac Stenting n=90 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort Improved	39 Participants
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort Maintained	44 Participants
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort Worsened	7 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: Population includes subjects available at 12 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 12 months.

Outcome measures

Measure	Iliac Stenting n=115 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression Improved	25 Participants
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression Maintained	82 Participants
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression Worsened	8 Participants

SECONDARY outcome

Timeframe: 24 Months

Population: Population includes subjects available at 24 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 24 months.

Outcome measures

Measure	Iliac Stenting n=103 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression Improved	25 Participants
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression Maintained	71 Participants
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression Worsened	7 Participants

SECONDARY outcome

Timeframe: 36 Months

Population: Population includes subjects available at 36 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 36 months.

Outcome measures

Measure	Iliac Stenting n=90 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression Improved	27 Participants
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression Maintained	58 Participants
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression Worsened	5 Participants

SECONDARY outcome

Timeframe: 12 Months

Population: Population includes subjects available at 12 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 12 months.

Outcome measures

Measure	Iliac Stenting n=114 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Own Health State Improved	23 Participants
Number of Participants With Change in Functional Status - EQ5D - Own Health State Maintained	77 Participants
Number of Participants With Change in Functional Status - EQ5D - Own Health State Worsened	14 Participants

SECONDARY outcome

Timeframe: 24 Months

Population: Population includes subjects available at 24 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 24 months.

Outcome measures

Measure	Iliac Stenting n=101 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Own Health State Improved	19 Participants
Number of Participants With Change in Functional Status - EQ5D - Own Health State Maintained	69 Participants
Number of Participants With Change in Functional Status - EQ5D - Own Health State Worsened	13 Participants

SECONDARY outcome

Timeframe: 36 Months

Population: Population includes subjects available at 36 months with relevant data.

Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Own Health State) from pre-procedure at 36 months.

Outcome measures

Measure	Iliac Stenting n=89 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Number of Participants With Change in Functional Status - EQ5D - Own Health State Improved	21 Participants
Number of Participants With Change in Functional Status - EQ5D - Own Health State Maintained	56 Participants
Number of Participants With Change in Functional Status - EQ5D - Own Health State Worsened	12 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 Days

Population: Population includes subjects followed for at least 30 days.

Number of subjects experiencing a device or procedure-related death within 30 Days - Component of primary outcome

Outcome measures

Measure	Iliac Stenting n=133 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Device or Procedure-related Death	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 Days

Population: Population includes subjects followed for at least 30 days.

Number of subjects experiencing a myocardial infarction (MI) within 30 Days - Component of primary outcome

Outcome measures

Measure	Iliac Stenting n=133 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Myocardial Infarction (MI)	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 Months

Population: Population includes subjects followed for at least 240 days.

Number of subjects experiencing a target lesion revascularization (TLR) within 9 months - Component of primary outcome

Outcome measures

Measure	Iliac Stenting n=132 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Target Lesion Revascularization (TLR)	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 9 Months

Population: Population includes subjects followed for at least 240 days.

Number of subjects experiencing a major amputation of the target limb within 9 months - Component of primary outcome

Outcome measures

Measure	Iliac Stenting n=132 Participants Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Major Amputation	0 Participants

Adverse Events

Iliac Stenting

Serious events: 30 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Iliac Stenting n=134 participants at risk Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.
Blood and lymphatic system disorders Hemorrhagic anemia	0.75% 1/134 • Number of events 1 • 9 months
Cardiac disorders Acute myocardial infarction	0.75% 1/134 • Number of events 1 • 9 months
Cardiac disorders Chest pain - cardiac	0.75% 1/134 • Number of events 1 • 9 months
Cardiac disorders Congestive cardiac failure aggravated	0.75% 1/134 • Number of events 1 • 9 months
Cardiac disorders Coronary artery disease	0.75% 1/134 • Number of events 1 • 9 months
Gastrointestinal disorders Gastrointestinal bleeding	0.75% 1/134 • Number of events 1 • 9 months
Gastrointestinal disorders Rectal bleeding	0.75% 1/134 • Number of events 1 • 9 months
Gastrointestinal disorders Umbilical hernia	0.75% 1/134 • Number of events 1 • 9 months
General disorders Chest pain (non-cardiac)	0.75% 1/134 • Number of events 1 • 9 months
General disorders Vascular stent occlusion	0.75% 1/134 • Number of events 1 • 9 months
Infections and infestations Clostridium difficile infection	0.75% 1/134 • Number of events 1 • 9 months
Infections and infestations Pneumonia	0.75% 1/134 • Number of events 1 • 9 months
Infections and infestations Surgical wound infection	0.75% 1/134 • Number of events 1 • 9 months
Infections and infestations Urinary tract infection	0.75% 1/134 • Number of events 1 • 9 months
Injury, poisoning and procedural complications Arterial restenosis	0.75% 1/134 • Number of events 1 • 9 months
Injury, poisoning and procedural complications Dislocation of ankle	0.75% 1/134 • Number of events 1 • 9 months
Injury, poisoning and procedural complications Humerus fracture	0.75% 1/134 • Number of events 1 • 9 months
Injury, poisoning and procedural complications Incisional hernia	0.75% 1/134 • Number of events 1 • 9 months
Injury, poisoning and procedural complications Postoperative hematoma	0.75% 1/134 • Number of events 1 • 9 months
Injury, poisoning and procedural complications Postoperative ileus	0.75% 1/134 • Number of events 1 • 9 months
Injury, poisoning and procedural complications Pseudoaneurysm	0.75% 1/134 • Number of events 1 • 9 months
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.75% 1/134 • Number of events 1 • 9 months
Injury, poisoning and procedural complications Wound dehiscence	1.5% 2/134 • Number of events 2 • 9 months
Metabolism and nutrition disorders Hyperkalemia	0.75% 1/134 • Number of events 1 • 9 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer of prostate	0.75% 1/134 • Number of events 1 • 9 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma	0.75% 1/134 • Number of events 1 • 9 months
Nervous system disorders Carotid artery stenosis	0.75% 1/134 • Number of events 1 • 9 months
Nervous system disorders Vascular dementia	0.75% 1/134 • Number of events 1 • 9 months
Renal and urinary disorders Acute kidney injury	0.75% 1/134 • Number of events 1 • 9 months
Respiratory, thoracic and mediastinal disorders COPD exacerbation	0.75% 1/134 • Number of events 1 • 9 months
Vascular disorders Claudication	1.5% 2/134 • Number of events 3 • 9 months
Vascular disorders Femoral artery dissection	0.75% 1/134 • Number of events 1 • 9 months
Vascular disorders Groin hematoma	0.75% 1/134 • Number of events 1 • 9 months
Vascular disorders Hypovolemic shock	0.75% 1/134 • Number of events 1 • 9 months
Vascular disorders Leg ischemia	0.75% 1/134 • Number of events 1 • 9 months
Vascular disorders Lymphocele	0.75% 1/134 • Number of events 1 • 9 months
Vascular disorders Peripheral arterial occlusive disease aggravated	0.75% 1/134 • Number of events 1 • 9 months
Vascular disorders Poor peripheral perfusion	0.75% 1/134 • Number of events 1 • 9 months
Vascular disorders Superficial femoral arterial stenosis	0.75% 1/134 • Number of events 1 • 9 months

Other adverse events

Adverse event data not reported

Additional Information

Hector R Novoa

W.L. Gore & Associates

Phone: 928-864-3867

Email: hnovoa@wlgore.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place