SuperB Trial: SUrgical Versus PERcutaneous Bypass

Study Overview
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Brief Summary
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In this multicentre Randomized Clinical Trial, the heparin-bonded endoluminal bypass will be compared to the surgical venous femoro-popliteal bypass, based on the non-inferiority principle for the patency. Besides equal patency, an improved quality of life is expected. Recruitment will take the first two years and patients will be followed during five years. Patients with an indication for surgical bypass, classified category 3-6 with a >50% stenosis or occlusion of the SFA over >/=10 cm in length will be included. At least one crural artery should be patent without significant lesions.

Official Title
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Heparin-bonded Endoluminal Versus Surgical Femoropopliteal Bypass; a Multicentre Randomized Controlled Trial

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Procedure: Heparin-bonded ePTFE endoluminal fem-pop bypass
* Procedure: Surgical femoro-popliteal bypass.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age over 18 years Informed consent Novo stenosis, restenosis >50% or occlusion of the native SFA, all > 10cm in length Patent popliteal artery at the upper margin of the patella to the trifurcation Diameter native SFA and popliteal artery are 5.0-7.5 mm Indication for surgical bypass Distal run-off at least one crural artery without significant stenosis Ankle-brachial index (ABI) at rest < 0.8 in the study limb prior to procedure Exclusion Criteria: Patient unsuitable for administration of contrast agent Pregnancy Dementia or altered mental status that would prohibit giving conscious informed consent Need for adjunctive major surgical or vascular procedures within one month Untreated flow-limiting aortoiliac occlusive disease Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment Femoral or popliteal aneurysm of target vessel Non-arthrotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis) Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancies, dementia etc.) or other medical condition that would preclude compliance with study protocol Major distal amputation (above the transmetatarsal) in the study limb Any previously known coagulation disorder, including hypercoagulability Contraindication to anticoagulation or antiplatelet therapy Known allergies to stent/stent-graft components History of prior life-threatening reaction to contrast agent Patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II Planned surgical procedure or major amputation to occur after enrollment of the patient

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heparin-bonded endoluminal fempop bypass<br>Heparin-bonded ePTFE endoluminal femoro-popliteal bypass versus surgical femoro-popliteal bypass | Procedure: Heparin-bonded ePTFE endoluminal fem-pop bypass<br>* Heparin-bonded ePTFE endoluminal femoropopliteal bypass versus surgical femoropopliteal bypass<br>|
| Active Comparator: Surgical femoro-popliteal bypass<br>Surgical femoro-popliteal bypass. | Procedure: Surgical femoro-popliteal bypass.<br>* Surgical femoro-popliteal bypass.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary (and -assisted) patency |  | 5 years | 
| Quality of life |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary patency |  | 5 years | 
| Complications |  | 5 years | 
| Clinical improvement |  | 5 years | 
| Re-intervention |  | 5 years | 
| Target lesion revascularisation |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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endoluminal, surgical, bypass, patency, quality of life, multicentre, RCT, superficial femoral artery, vascular patency