GORE VIABAHN® Versus Plain Old Balloon Angioplasty (POBA) for Superficial Femoral Artery (SFA) In-Stent Restenosis (RELINE)

Flanders Medical Research Program

Status and phase

Completed

Phase 4

Conditions

Peripheral Vascular Disease

Treatments

Device: GORE VIABAHN® Endoprosthesis

Device: Plain old balloon angioplasty

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT01108861

FMRP-100107

Details and patient eligibility

About

This is a prospective, randomized, multi-center study recruiting patients with an in-stent restenosis in the superficial femoral artery. The safety and efficacity of the Viabahn endoprosthesis (W.L. Gore & Associates), a heparin-bonded endoprosthesis, is compared with plain old balloon angioplasty (POBA). In 4 Belgian and 2 German centers a total of 80 Patients will be recruited. Primary endpoint is primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (CFDU) measuring a peak systolic velocity ratio ≤2.5, and without target lesion revascularization (TLR) within 12 months.

In comparison to POBA, it is expected that the use of the Viabahn endoprosthesis (W.L. Gore & Associates) will result in greater 12 month primary patency of treated superficial femoral artery in-stent restenotic lesions.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

General Inclusion Criteria:

Patient presenting with lifestyle-limiting claudication, rest pain or minor tissue loss (Rutherford classification from 2 to 5)
Patient is willing to comply with specified follow-up evaluations at the specified times
Patient is >18 years old
Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
Patient has a projected life-expectancy of at least 24 months
Noninvasive lower extremity arterial studies (resting or exercise) demonstrate ankle-brachial index ≤0.8
Patient is eligible for treatment with the Viabahn® Endoprosthesis (W.L. Gore)
Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure

Angiographic Inclusion Criteria

Restenotic or reoccluded lesion located in a stent which was previously implanted (>30 days) in the superficial femoral artery, suitable for endovascular therapy
Total target lesion length between 4 and 27 cm (comprising in-stent restenosis and adjacent stenotic disease)
Minimum of 1.0cm of healthy vessel (non-stenotic) both proximal and distal to the treatment area
Popliteal artery is patent at the intercondylar fossa of the femur to P3
Target vessel diameter visually estimated to be >4mm and <7.6 mm at the proximal and distal treatment segments within the SFA
Guidewire and delivery system successfully traversed lesion
There is angiographic evidence of at least one-vessel-runoff to the foot, that does not require intervention (<50% stenotic)

Exclusion criteria :

Untreated flow-limiting aortoiliac stenotic disease
Presence of a chronic total occlusion, i.e. a complete occlusion of the failed bare stent that cannot be re-opened with thrombolysis or does not allow easy passage of the guidewire by the physician
Any previous surgery in the target vessel
Severe ipsilateral common/deep femoral disease requiring surgical reintervention
Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
Femoral or popliteal aneurysm located at the target vessel
Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
No patent tibial arteries (>50% stenosis)
Prior ipsilateral femoral artery bypass
Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 2-year life expectancy
Serum creatinine >2.5mg/dL within 45 days prior to study procedure unless the subject is currently on dialysis
Major distal amputation (above the transmetatarsal) in the study or non-study limb
Septicemia or bacteremia
Any previously known coagulation disorder, including hypercoagulability
Contraindication to anticoagulation or antiplatelet therapy
Known allergies to stent or stent graft components (nickel-titanium or ePTFE)
Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
Patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
Currently participating in another clinical research trial, unless approved by W.L. Gore & Associates in advance of study enrolment
Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment
Any planned surgical intervention/procedure within 30 days of the study procedure
Target lesion access not performed by transfemoral approach.