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

Evaluation of the Gore(R) Viabahn(R) Balloon Expandable Endoprosthesis (VIABAHN BX) for the Treatment of Occlusive Disease in the Common and External Iliac Arteries.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02080871

Acronym

VBXFLEX

Enrollment

134

Registered

2014-03-06

Start date

2014-07-31

Completion date

2018-10-31

Last updated

2019-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Keywords

PAD, Stent, Claudication, Viabahn, Gore, Endoprosthesis, Vascular Diseases, Cardiovascular Diseases, Iliac Occlusive Disease, Balloon Expandable, Stent-graft, VBX

Brief summary

Evaluation of the Gore(R) VIABAHN BX for the treatment of arterial occlusive disease in the common and/or external iliac arteries.

Detailed description

This study is a prospective, multicenter, non-randomized single-arm clinical study to evaluate the safety and efficacy of the VIABAHN BX for the treatment of arterial occlusive disease in patients with de novo or restenotic lesions in the common and/or external iliac arteries.

Interventions

DEVICEStenting of the Common and/or External Iliac Arteries

Balloon expandable stenting of iliac occlusive disease.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patient is at least 18 years old; 2. Patient is male, infertile female, or female of childbearing potential practicing an acceptable method of preventing pregnancy; 3. Patient or legal representative is willing to give written informed consent; 4. Patient is capable of complying with protocol requirements, including all follow-up visits; 5. Patient has symptomatic claudication or rest pain without tissue loss (Rutherford Categories 2-4). 6. Patient has de novo or restenotic target lesion(s) in the common and/or external iliac artery; 7. Patient has one or more regions of stenosis ≥ 50% in the target vessel, based on visual estimate; 8. Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm; 9. Patient has adequate ipsilateral blood flow including at least one sufficient (\<50% stenotic) infrapopliteal run-off vessel not requiring intervention (per side to be intervened on). 10. Patient has a total target lesion length visually estimated to be ≤110 mm which can be treated with a maximum of three VIABAHN BX endoprostheses; 11. Patient has no more than two discrete ipsilateral lesions that can be treated with no more than three VIABAHN BX endoprostheses \[OR\] Patient has bilateral disease consisting of only one target lesion per side that can be treated with no more than a total of three VIABAHN BX endoprostheses; 12. Patient has the device advanced across the target lesion(s) and positioned for deployment.

Exclusion criteria

1. Patient has a life expectancy of less than 1 year; 2. Patient has a known allergy to stent graft components, including stainless steel or heparin; 3. Patient has a known intolerance to antiplatelet, anticoagulant, or thrombolytic medications that would prevent compliance with the protocol; 4. Patient has a condition (unrelated to the study) that is expected to require indefinite, or lifelong, anticoagulation 5. Patient has an uncorrected bleeding disorder (platelet count \< 80,000/µL); 6. Patient has severe chronic renal insufficiency (serum creatinine level \> 2.5mg/dL) and not on hemodialysis; 7. Patient has a known hypercoagulability that cannot be corrected; 8. Patient has evidence of a blood borne infection; 9. Patient has had vascular access/catheterization in the lower extremity within 30 days of study enrollment; 10. Patient has had a previous or planned coronary intervention within 30 days prior to enrollment in this study or required at time of study procedure; 11. Patient has had a previous or planned bypass surgery in the target leg, or a bypass that occurs at the time of the index procedure; 12. Patient is currently participating in this or another investigative clinical study. 13. Patient has a stent or stent graft located within or immediately adjacent (≤5mm) to study lesion(s); 14. Patient has evidence of angiographically visible thrombus within or adjacent to the target lesion(s); 15. Patient has aneurysmal dilation proximal or distal to the target lesion(s) that would interfere with the placement of the device; 16. Patient has a target lesion requiring atherectomy or any ablative device to facilitate stent delivery; 17. Patient has a target lesion situated in such a way that an implanted device will prevent blood flow or perfusion to the internal iliac artery if patent.

Design outcomes

Primary

Measure	Time frame	Description
Composite of Major Adverse Events (MAEs)	9 months	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.

Secondary

Measure	Time frame	Description
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)	30 Days	Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days.
Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	30 Days	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Anxiety/Depression) from pre-procedure at 30 days.
Number of Participants With Change in Functional Status - EQ5D - Own Health State	30 Days	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.
Number of Participants With Improvement in Functional Status at 30 Days - Walking Improvement Questionnaire (WIQ)	30 Days	Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 30 days.
Number of Participants With Improvement in Functional Status 9 Months - Walking Improvement Questionnaire (WIQ)	9 Months	Patient reported outcome based on study questionnaire. Percentage of subjects with improvement on WIQ from pre-procedure at 9 months.
Number of Participants With Change in Functional Status - EQ5D - Mobility	30 Days	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Mobility) from pre-procedure at 30 days.
Change in Ankle Brachial Index (ABI)	30 Days	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.
Number of Participants With Change in Rutherford Category	30 Days	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
Acute Procedural Success	Discharge	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.
30-Day Clinical Success	30 Days	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.
Percentage of Participants With Primary Patency	30 Days	Kaplan-Meier estimate of primary patency at 30 days.
Percentage of Participants With Primary Assisted Patency	30 Days	Kaplan-Meier estimate of primary assisted patency at 30 days.
Percentage of Participants With Secondary Patency	30 Days	Kaplan-Meier estimate of secondary patency at 30 days.
Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)	30 Days	Kaplan-Meier estimate of freedom from clinically-driven target lesion revascularization (CD-TLR) at 30 days.
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)	30 Days	Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days.
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)	30 Days	Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 30 days.
Number of Participants With Change in Functional Status - EQ5D - Self Care	30 Days	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Self Care) from pre-procedure at 30 days.
Number of Participants With Change in Functional Status - EQ5D - Usual Activities	30 Days	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Usual Activities) from pre-procedure at 30 days.
Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	30 Days	Patient reported outcome based on study questionnaire. Number of participants with change in functional status (EQ5D - Pain/Discomfort) from pre-procedure at 30 days.

Other

Measure	Time frame	Description
Target Lesion Revascularization (TLR)	9 Months	Number of subjects experiencing a target lesion revascularization (TLR) within 9 months - Component of primary outcome
Major Amputation	9 Months	Number of subjects experiencing a major amputation of the target limb within 9 months - Component of primary outcome
Device or Procedure-related Death	30 Days	Number of subjects experiencing a device or procedure-related death within 30 Days - Component of primary outcome
Myocardial Infarction (MI)	30 Days	Number of subjects experiencing a myocardial infarction (MI) within 30 Days - Component of primary outcome

Countries

New Zealand, United States

Participant flow

Participants by arm

Arm	Count
Iliac Stenting Balloon expandable stenting of iliac occlusive disease Stenting of the Common and/or External Iliac Arteries: Balloon expandable stenting of iliac occlusive disease.	134
Total	134

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	1
Overall Study	Lost to Follow-up	1

Baseline characteristics

Characteristic	Iliac Stenting
Age, Continuous	66 years STANDARD_DEVIATION 9.5
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	128 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants
Race (NIH/OMB) Asian	2 Participants
Race (NIH/OMB) Black or African American	4 Participants
Race (NIH/OMB) More than one race	1 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants
Race (NIH/OMB) White	122 Participants
Region of Enrollment New Zealand	27 Participants
Region of Enrollment United States	107 Participants
Sex: Female, Male Female	79 Participants
Sex: Female, Male Male	55 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	1 / 134
other Total, other adverse events	0 / 134
serious Total, serious adverse events	30 / 134

Outcome results

Primary

Composite of Major Adverse Events (MAEs)

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.

Time frame: 9 months

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

Arm	Measure	Value (NUMBER)
Iliac Stenting	Composite of Major Adverse Events (MAEs)	2.3 percentage of subjects experiencing MAE

Comparison: The sample size obtains over 90% power to statistically show the probability that a subject will experience an MAE with use of the study device is less than 17% when 12% or less of the subjects are lost to follow up prior to 9 months.p-value: <0.001one-sided binomial exact test

Secondary

30-Day Clinical Success

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.

Time frame: 30 Days

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	30-Day Clinical Success	108 Participants

Secondary

Acute Procedural Success

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.

Time frame: Discharge

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Acute Procedural Success	130 Participants

Secondary

Change in Ankle Brachial Index (ABI)

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.

Time frame: 12 Months

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

Arm	Measure	Value (MEAN)
Iliac Stenting	Change in Ankle Brachial Index (ABI)	0.19 ratio index

Secondary

Change in Ankle Brachial Index (ABI)

Time frame: 9 Months

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

Arm	Measure	Value (MEAN)
Iliac Stenting	Change in Ankle Brachial Index (ABI)	0.97 ratio index

Secondary

Change in Ankle Brachial Index (ABI)

Time frame: 36 Months

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

Arm	Measure	Value (MEAN)
Iliac Stenting	Change in Ankle Brachial Index (ABI)	0.17 ratio index

Secondary

Change in Ankle Brachial Index (ABI)

Time frame: 30 Days

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

Arm	Measure	Value (MEAN)
Iliac Stenting	Change in Ankle Brachial Index (ABI)	.97 ratio index

Secondary

Change in Ankle Brachial Index (ABI)

Time frame: 24 Months

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

Arm	Measure	Value (MEAN)
Iliac Stenting	Change in Ankle Brachial Index (ABI)	.17 ratio index

Secondary

Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression

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

Time frame: 9 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Improved	28 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Maintained	79 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Worsened	7 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression

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

Time frame: 36 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Improved	27 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Maintained	58 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Worsened	5 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression

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

Time frame: 24 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Improved	25 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Maintained	71 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Worsened	7 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression

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

Time frame: 12 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Improved	25 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Maintained	82 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Worsened	8 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression

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

Time frame: 30 Days

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Improved	27 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Maintained	82 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Anxiety/Depression	Worsened	6 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Mobility

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

Time frame: 9 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Mobility	Improved	48 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Mobility	Maintained	62 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Mobility	Worsened	4 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Mobility

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

Time frame: 12 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Mobility	Improved	44 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Mobility	Maintained	66 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Mobility	Worsened	5 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Mobility

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

Time frame: 24 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Mobility	Improved	45 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Mobility	Maintained	53 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Mobility	Worsened	5 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Mobility

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

Time frame: 36 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Mobility	Improved	43 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Mobility	Maintained	43 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Mobility	Worsened	4 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Mobility

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

Time frame: 30 Days

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Mobility	Improved	51 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Mobility	Maintained	57 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Mobility	Worsened	7 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Own Health State

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.

Time frame: 24 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Improved	19 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Maintained	69 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Worsened	13 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Own Health State

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.

Time frame: 12 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Improved	23 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Maintained	77 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Worsened	14 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Own Health State

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.

Time frame: 30 Days

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Improved	22 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Maintained	84 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Worsened	8 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Own Health State

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.

Time frame: 36 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Improved	21 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Maintained	56 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Worsened	12 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Own Health State

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.

Time frame: 9 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Improved	23 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Maintained	73 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Own Health State	Worsened	17 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort

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

Time frame: 30 Days

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Improved	56 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Maintained	49 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Worsened	10 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort

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

Time frame: 36 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Improved	39 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Maintained	44 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Worsened	7 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort

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

Time frame: 24 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Improved	49 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Maintained	41 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Worsened	13 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort

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

Time frame: 12 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Improved	59 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Maintained	44 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Worsened	12 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort

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

Time frame: 9 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Improved	49 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Maintained	55 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Pain/Discomfort	Worsened	10 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Self Care

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

Time frame: 36 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Self Care	Improved	4 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Self Care	Maintained	84 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Self Care	Worsened	2 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Self Care

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

Time frame: 30 Days

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Self Care	Improved	5 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Self Care	Maintained	108 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Self Care	Worsened	2 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Self Care

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

Time frame: 9 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Self Care	Improved	6 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Self Care	Maintained	105 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Self Care	Worsened	3 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Self Care

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

Time frame: 24 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Self Care	Improved	5 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Self Care	Maintained	93 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Self Care	Worsened	5 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Self Care

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

Time frame: 12 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Self Care	Improved	6 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Self Care	Maintained	106 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Self Care	Worsened	3 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Usual Activities

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

Time frame: 24 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Improved	44 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Maintained	51 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Worsened	8 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Usual Activities

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

Time frame: 12 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Improved	51 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Maintained	55 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Worsened	9 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Usual Activities

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

Time frame: 36 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Improved	44 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Maintained	42 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Worsened	4 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Usual Activities

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

Time frame: 30 Days

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Improved	52 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Maintained	55 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Worsened	8 Participants

Secondary

Number of Participants With Change in Functional Status - EQ5D - Usual Activities

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

Time frame: 9 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Improved	53 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Maintained	57 Participants
Iliac Stenting	Number of Participants With Change in Functional Status - EQ5D - Usual Activities	Worsened	4 Participants

Secondary

Number of Participants With Change in Rutherford Category

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

Time frame: 36 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Rutherford Category	Improved Rutherford Category	82 Participants
Iliac Stenting	Number of Participants With Change in Rutherford Category	Maintained Rutherford Category	7 Participants
Iliac Stenting	Number of Participants With Change in Rutherford Category	Worsened Rutherford Category	0 Participants

Secondary

Number of Participants With Change in Rutherford Category

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

Time frame: 12 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Rutherford Category	Improved Rutherford Category	108 Participants
Iliac Stenting	Number of Participants With Change in Rutherford Category	Maintained Rutherford Category	6 Participants
Iliac Stenting	Number of Participants With Change in Rutherford Category	Worsened Rutherford Category	0 Participants

Secondary

Number of Participants With Change in Rutherford Category

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

Time frame: 30 Days

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Rutherford Category	Improved Rutherford Category	111 Participants
Iliac Stenting	Number of Participants With Change in Rutherford Category	Maintained Rutherford Category	6 Participants
Iliac Stenting	Number of Participants With Change in Rutherford Category	Worsened Rutherford Category	1 Participants

Secondary

Number of Participants With Change in Rutherford Category

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

Time frame: 24 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Rutherford Category	Improved Rutherford Category	96 Participants
Iliac Stenting	Number of Participants With Change in Rutherford Category	Maintained Rutherford Category	5 Participants
Iliac Stenting	Number of Participants With Change in Rutherford Category	Worsened Rutherford Category	1 Participants

Secondary

Number of Participants With Change in Rutherford Category

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

Time frame: 9 Months

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

Arm	Measure	Category	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Change in Rutherford Category	Improved Rutherford Category	106 Participants
Iliac Stenting	Number of Participants With Change in Rutherford Category	Maintained Rutherford Category	6 Participants
Iliac Stenting	Number of Participants With Change in Rutherford Category	Worsened Rutherford Category	0 Participants

Secondary

Number of Participants With Improvement in Functional Status 9 Months - Walking Improvement Questionnaire (WIQ)

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

Time frame: 9 Months

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Improvement in Functional Status 9 Months - Walking Improvement Questionnaire (WIQ)	102 Participants

Secondary

Number of Participants With Improvement in Functional Status at 30 Days - Walking Improvement Questionnaire (WIQ)

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

Time frame: 30 Days

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

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Iliac Stenting	Number of Participants With Improvement in Functional Status at 30 Days - Walking Improvement Questionnaire (WIQ)	106 Participants

Secondary

Percentage of Participants With Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR)

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

Time frame: 30 Days