In-Stent Restenosis Post-Approval Study

W.L. Gore & Associates

Status

Completed

Conditions

Vascular Disease

Peripheral Artery Disease

Treatments

Device: Gore VIABAHN Endoprosthesis

Study type

Interventional

Funder types

Industry

Identifiers

NCT02542267

ISR 14-04

Details and patient eligibility

About

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.

Enrollment

108 patients

Sex

All

Ages

18+ years old

Volunteers

No 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
Note: Additional Inclusion Criteria may apply

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
Note: Additional Exclusion Criteria may apply