Cardiovascular Diseases
Conditions
Keywords
endoluminal, surgical, bypass, patency, quality of life, multicentre, RCT, superficial femoral artery, vascular patency
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 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.
Interventions
PROCEDUREHeparin-bonded ePTFE endoluminal fem-pop bypass
Heparin-bonded ePTFE endoluminal femoropopliteal bypass versus surgical femoropopliteal bypass
PROCEDURESurgical femoro-popliteal bypass.
Surgical femoro-popliteal bypass.
Sponsors
Rijnstate Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary (and -assisted) patency | 5 years |
| Quality of life | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Clinical improvement | 5 years |
| Secondary patency | 5 years |
| Target lesion revascularisation | 5 years |
| Re-intervention | 5 years |
| Complications | 5 years |
Countries
Netherlands
Outcome results
None listed