SuperB Trial: SUrgical Versus PERcutaneous Bypass

Rijnstate Hospital

Status

Completed

Conditions

Cardiovascular Diseases

Treatments

Procedure: Heparin-bonded ePTFE endoluminal fem-pop bypass

Procedure: Surgical femoro-popliteal bypass.

Study type

Interventional

Funder types

Other

Identifiers

NCT01220245

721-070910

Details and patient eligibility

About

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.

Enrollment

129 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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