Completed
Post-Approval Study of the GORE® VIABAHN® Endoprosthesis for the Treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)
What is being tested
Gore VIABAHN Endoprosthesis
Device
Who is being recruted
Arterial Occlusive Diseases+4
+ Arteriosclerosis
+ Cardiovascular Diseases
Over 18 Years
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: September 2015
Summary
Principal SponsorW.L.Gore & Associates
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2015
Actual date on which the first participant was enrolled.The objective of the ISR 14-04 study is to evaluate post-market safety and effectiveness of GORE® VIABAHN® Endoprosthesis for treatment of In-Stent Restenosis of the Superficial Femoral Artery.
Official TitlePost-Approval Study of the GORE® VIABAHN® Endoprosthesis for the Treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)
Principal SponsorW.L.Gore & Associates
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
108 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Arterial Occlusive DiseasesArteriosclerosisCardiovascular DiseasesVascular DiseasesPeripheral Vascular DiseasesAtherosclerosisPeripheral Arterial Disease
Criteria
8 inclusion criteria required to participate
Patient has a previously implanted (> 30 days) non-covered stent(s) located in the SFA
Patient has life-style limiting claudication, resting leg pain or minor tissue loss (Rutherford Category 2 - 5)
Patient demonstrates an Ankle Brachial Index (ABI) <=0.9. If ABI >0.9 or not measurable, patient is eligible for study if Toe Brachial Index is <=0.5
Patient has >=50% in-stent restenosis and / or an occlusion in a previously implanted (>30 days) non-covered stent(s) located in the superficial femoral artery defined as beginning at least 1cm below the origin of the profunda femoris artery and ending at least 1cm above the intercondylar notch.
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8 exclusion criteria prevent from participating
Patient has a known allergy to stent graft components (nickel-titanium or expanded-polytetrafluoroethylene)
Patient has a known intolerance to anticoagulation or antiplatelet therapy
Patient has known coagulation disorder, including hypercoagulability.
Patient has major distal amputation (above the transmetatarsal)
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Gore VIABAHN Endoprosthesis deployed to treat failed non-covered stent(s) in the Superficial Femoral Artery
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 23 locations
Suspended
Suspended
Kaiser Foundation Hospital
Honolulu, United StatesSuspended
Rockford CardioVascular Associates
Rockford, United StatesSuspended
University of Iowa Hospitals and Clinics
Iowa City, United StatesCompleted23 Study Centers