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

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.

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

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Stenting of 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.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand
    • Auckland City Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • St. Luke's Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06518
      • Yale University School Of Medicine
  • District of Columbia
    • Washington, District of Columbia, United States, 20782
      • MedStar Health Research Institute
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami
    • Miami, Florida, United States, 33176
      • Baptist Cardiac and Vascular Institute
    • Pensacola, Florida, United States, 32504
      • Coastal Vascular Institute
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Cardiovascular Associates
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Methodist Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Minnesota
    • Duluth, Minnesota, United States, 55805
      • Essentia Institute for Rural Health / St Mary's Hospital
    • Plymouth, Minnesota, United States, 55422
      • North Memorial Heart & Vascular Institute
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Advanced Vascular Associates
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center
  • New York
    • Buffalo, New York, United States, 14203
      • Research Foundation SUNY Buffalo
    • New York, New York, United States, 10065
      • Cornell University
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • Sanford Clinic - Clinical Research
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Ohio Health
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Holy Spirit Cardiovascular Institute
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • MUSC
    • Greenville, South Carolina, United States, 29615
      • Greenville Memorial Hospital
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • University Surgical Associates
    • Kingsport, Tennessee, United States, 37660
      • Wellmont Holston Valley Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • The Methodist Hospital
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gore VIABAHN BX; Balloon expandable stenting of iliac occlusive disease	Device: Stenting of the Common and/or External Iliac Arteries; Balloon expandable stenting of iliac occlusive disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Discharge
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.	30 Days
Percentage of Participants With Primary Patency	Kaplan-Meier estimate of primary patency at 30 days.	30 Days
Percentage of Participants With Primary Patency	Kaplan-Meier estimate of primary patency at 9 months.	9 Months
Percentage of Participants With Primary Assisted Patency	Kaplan-Meier estimate of primary assisted patency at 30 days.	30 Days
Percentage of Participants With Primary Assisted Patency	Kaplan-Meier estimate of primary assisted patency at 9 months.	9 Months
Percentage of Participants With Secondary Patency	Kaplan-Meier estimate of secondary patency at 30 days.	30 Days
Percentage of Participants With Secondary Patency	Kaplan-Meier estimate of secondary patency at 9 months.	9 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)	Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 30 days.	30 Days
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)	Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 9 months.	9 Months
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.	30 Days
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 9 months.	9 Months
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)	Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 30 days.	30 Days
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)	Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 9 months.	9 Months
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)	Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 30 days.	30 Days
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)	Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 9 months	9 Months
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	30 Days
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	9 Months
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.	30 Days
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.	9 Months
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.	30 Days
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.	9 Months
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.	30 Days
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.	9 Months
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.	30 Days
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.	9 Months
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.	30 Days
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.	9 Months
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.	30 Days
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.	9 Months
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.	30 Days
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.	9 Months
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.	30 Days
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.	9 Months
Percentage of Participants With Primary Patency	Kaplan-Meier estimate of primary patency at 12 months.	12 Months
Percentage of Participants With Primary Assisted Patency	Kaplan-Meier estimate of primary assisted patency at 12 months.	12 Months
Percentage of Participants With Secondary Patency	Kaplan-Meier estimate of secondary patency at 12 months.	12 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)	Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 12 months.	12 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)	Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 24 months.	24 Months
Percentage of Participants With Freedom From Target Lesion Revascularization (TLR)	Kaplan-Meier estimate of freedom from target lesion revascularization (TLR) at 36 months.	36 Months
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 12 months.	12 Months
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 24 months.	24 Months
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 36 months.	36 Months
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)	Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 12 months.	12 Months
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)	Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 24 months.	24 Months
Percentage of Participants With Freedom From Target Vessel Revascularization (TVR)	Kaplan-Meier estimate of freedom from target vessel revascularization (TVR) at 36 months.	36 Months
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)	Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 12 months	12 Months
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)	Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 24 months	24 Months
Percentage of Participants With Freedom From Clinically-Driven Target Vessel Revascularization (CD-TVR)	Kaplan-Meier estimate of freedom from clinically-driven target vessel revascularization (CD-TVR) at 36 months	36 Months
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	12 Months
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	24 Months
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	36 Months
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.	12 Months
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.	24 Months
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.	36 Months
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.	12 Months
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.	24 Months
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.	36 Months
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.	12 Months
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.	24 Months
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.	36 Months
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.	12 Months
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.	24 Months
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.	36 Months
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.	12 Months
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.	24 Months
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.	36 Months
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.	12 Months
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.	24 Months
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.	36 Months
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.	12 Months
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.	24 Months
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.	36 Months

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: W.L.Gore & Associates
• Investigators: Principal Investigator: Jean Bismuth, MD, The Methodist Hospital Research Institute

Publications and helpful links

General Publications

• Panneton JM, Bismuth J, Gray BH, Holden A. Three-Year Follow-up of Patients With Iliac Occlusive Disease Treated With the Viabahn Balloon- Expandable Endoprosthesis. J Endovasc Ther. 2020 Oct;27(5):728-736. doi: 10.1177/1526602820920569. Epub 2020 Apr 24.
• Bismuth J, Gray BH, Holden A, Metzger C, Panneton J; VBX FLEX Study Investigators. Pivotal Study of a Next-Generation Balloon-Expandable Stent-Graft for Treatment of Iliac Occlusive Disease. J Endovasc Ther. 2017 Oct;24(5):629-637. doi: 10.1177/1526602817720463. Epub 2017 Jul 12.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): October 1, 2018

Study Registration Dates

• First Submitted: March 4, 2014
• First Submitted That Met QC Criteria: March 5, 2014
• First Posted (Estimate): March 6, 2014

Study Record Updates

• Last Update Posted (Actual): January 16, 2019
• Last Update Submitted That Met QC Criteria: December 27, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: PAD; Stent; Claudication; Viabahn; Gore; Endoprosthesis; Vascular Diseases; Cardiovascular Diseases; Iliac Occlusive Disease; Balloon Expandable; Stent-graft; VBX
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: BES 10-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No