Vascular Diseases Clinical Trial
Official title:
The Study to Compare the Treatment of Stent and Prothesis Bypass in SFA Occlusions
Different strategies exist in the treatment of chronic long occlusion of the superficial femoral artery. Traditionally, these patients should be treated with bypass. If the great saphenous vein is unavailable, doctor has to choose artificial vessel as graft. Now, the skill of endovascular treatment is developing rapidly, and lots of doctors think most of such patients could be treated with stent. The purpose of this trial is to compare stent and artificial blood vessel bypass in the treatment of long occlusion of the superficial femoral artery. The study hypothesis is that patency rates are comparable and therefore the minimal invasive treatment of stent can be considered in such patients.
This is a multi-center, prospective, randomized, controlled trial to compare the therapeutic
effect of stent and artificial blood vessel bypass to chronic long occlusion of the
superficial femoral artery. Totally 200 patients will be entered into the trial. The study
population will consist of patients with long superficial femoral stenosis and occlusion
lesion (≥15 cm), presenting symptomatic ischemia（Rutherford 3-6）. The lesion does not extend
beyond the aortoiliac artery or blow-knee popliteal artery, with at least 1 vessel
infra-popliteal runoff to the foot.
Trial participants will be randomized to either stent group or artificial blood vessel
bypass group.
Patients will be followed up for 3 years. Study examinations will be done at screening,
procedure time, 1, 6, 12, 24 and 36 months after procedure.
This study will be conducted at 3 centers in Beijing, China.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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