Status:
COMPLETED
SuperB Trial: SUrgical Versus PERcutaneous Bypass
Lead Sponsor:
Rijnstate Hospital
Conditions:
Cardiovascular Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 pat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT01220245
Start Date
October 1 2010
End Date
August 1 2020
Last Update
January 25 2021
Active Locations (6)
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1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands
2
Slingeland Hospital
Doetinchem, Gelderland, Netherlands
3
Isala klinieken
Zwolle, Overijssel, Netherlands
4
Nij Smellinghe Hospital
Drachten, Provincie Friesland, Netherlands