In-Stent Restenosis Post-Approval Study

Completed · Not applicable

Conditions studied: Peripheral Artery Disease, Vascular Disease

In brief

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.

Key facts

Study ID: NCT02542267
Run by: W.L.Gore & Associates
People needed: 108
Starts: 2015-09-01
Expected to finish: 2021-07-01
Last updated by the study team: 2023-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
Note: Additional Inclusion Criteria may apply

You may not qualify if…

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
Note: Additional Exclusion Criteria may apply

Where it is running

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
North Carolina Heart and Vascular — Raleigh, North Carolina, United States
Sanford Health — Fargo, North Dakota, United States
Providence Heart Clinic — Portland, Oregon, United States
St. Vincent's Consultants in Cardiovascular Disease — Erie, Pennsylvania, United States
The Miriam Hospital — Providence, Rhode Island, United States
Greenville Hospital System — Greenville, South Carolina, United States
Texas Health Research - Presbyterian Heart and Vascular — Dallas, Texas, United States
Texas Health Research - Presbyterian Hospital of Plano — Plano, Texas, United States
Swedish Medical Center - Heart and Vascular Research — Seattle, Washington, United States
Charleston Area Medical Center — Charleston, West Virginia, United States
Klinikum Rosenheim — Rosenheim, Germany
Azienda Ospedaliera Santa Maria Nuova di Reggio Emilia — Reggio Emilia, Italy
Skånes Universitetssjukhus — Malmö, Sweden

Full record on ClinicalTrials.gov

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