arteriosclerosis vascular disease
Conditions
Interventions
Patients are randomised between surgical venous femoropopliteal bypass and
endoluminal stent-graft
Sponsors
Alysis Zorggroep
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: patients over 18 years of age informed consent >10 cm stenosis or occlusion of the SFA or popliteal artery, nort extending below knee level rutherford category 3-6 indication for surgical bypass distal runoff of one or more vessels resting ABI 50%) of occlusion of the native SFA orifice and proximal 1 cm of SFA are patent popliteal artery is patent at P2 segment to the trifurcation diameter of native SFA and popliteal artery are 4.3-7.5 mm
Exclusion criteria
Exclusion criteria: patient unsuitable for administration of contrast agent (previous lifethreathening reaction) pregnancy dementia or altered mental status that would prohibit giving conscious informed consent need for major surgical or vascular procedures within one month untreated flowlimiting aortoiliac occlusive disease any previous stenting or surgery in the target vessel severe ipsilateral common femoral/profunda disease requiring surgical intervention perioperative unsuccesful ipsilateral percutaneous vascular procedure to treat inflow disease prior to enrollment femoral or popliteal aneurysm of target vessel non-artherosclerotic disease resulting in occlusion (eg embolism, Buerger's disease, vasculitis) prior ipsilateral femoral artery bypass severe medical comorbidities or other medical condition that would preclude compliance with study protocol serum creatinine >2,5 mg/dL within 45 days prior to study procedure unless subject is currently on dialysis major distal amputation (above the transmetatarsal) in ther study or non-study limb septicemia or bacteremia any previously known coagulation disorder contraindication to anticoagulation or antiplatelet therapy Known allergies to stent/stentgraft components patients with known hypersensitivity to heparin including those who have had a previous incidence of heparin induced thrombocytopenia type II planned surgical procedure or amputation after enrollment of the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints: Primary, primary-assisted and secondary patency | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundaire endpoints: Complications Clinical improvement Surgical and endovascular re-interventions Quality of Life target lesion revascularization Subgroup analysis: -patients with disabling claudication (Rutherford 3) will be analyzed separately using pain-free and maximal walking distance as additional endpoint - patients with ischemic restpain and necrosis (Rutherford 4-6) will be analyzed using limb salvage and major amputation as endpoints | — |
Countries
Netherlands
Outcome results
None listed