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In-Stent Restenosis Post-Approval Study | Clinical Trials | Clareo Health

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In-Stent Restenosis Post-Approval Study

Post-Approval Study of the GORE® VIABAHN® Endoprosthesis for the Treatment of In-Stent Restenosis (ISR) in the Superficial Femoral Artery (SFA)

NCT02542267•W.L.Gore & Associates

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•Patient has a maximum total lesion length of 270mm, consisting of in-stent and adjacent occlusive disease
•Patient has a reference vessel diameter between 4.0 and 6.5mm
•Patient has at least one patent infrapopliteal runoff vessel (\<50% stenosis) not requiring reintervention

Exclusion Criteria

•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)
•Patient has any previous surgery in the target vessel
•Patient has had previous target vessel in-stent restenosis treated by relining with another stent
•Patient has untreated flow-limiting aortoiliac stenotic disease

Locations (23)

Mount Sinai Medical Center

Miami, Florida, United States

Kaiser Foundation Hospital

Honolulu, Hawaii, United States

Rockford CardioVascular Associates

Rockford, Illinois, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Cardiovascular Institute of the South

Houma, Louisiana, United States

Covenant Medical Center, Inc.

Saginaw, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

Midwest Aortic and Vascular Institute (MAVI)

North Kansas City, Missouri, United States

New York University Langone Medical Center

New York, New York, United States

New York Presbyterian Hospital/Weill Cornell Medical Center

New York, New York, United States

Key Dates

Start Date

September 1, 2015

Primary Completion Date

July 1, 2019

Completion Date

July 1, 2021

Last Updated

October 16, 2023

Enrollment

108

ACTUAL participants

Conditions

Peripheral Artery DiseaseVascular Disease

Interventions

Gore VIABAHN Endoprosthesis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 16, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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In-Stent Restenosis Post-Approval Study

Inclusion Criteria

Exclusion Criteria

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