SuperB Trial: SUrgical Versus PERcutaneous Bypass

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

129 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2020-08-31

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.

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Detailed Description

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Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Heparin-bonded endoluminal fempop bypass

Heparin-bonded ePTFE endoluminal femoro-popliteal bypass versus surgical femoro-popliteal bypass

Group Type EXPERIMENTAL

Heparin-bonded ePTFE endoluminal fem-pop bypass

Intervention Type PROCEDURE

Heparin-bonded ePTFE endoluminal femoropopliteal bypass versus surgical femoropopliteal bypass

Surgical femoro-popliteal bypass

Surgical femoro-popliteal bypass.

Group Type ACTIVE_COMPARATOR

Surgical femoro-popliteal bypass.

Intervention Type PROCEDURE

Surgical femoro-popliteal bypass.

Interventions

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Heparin-bonded ePTFE endoluminal fem-pop bypass

Heparin-bonded ePTFE endoluminal femoropopliteal bypass versus surgical femoropopliteal bypass

Intervention Type PROCEDURE

Surgical femoro-popliteal bypass.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No