Comparison of Stent and Prothesis Bypass in Superficial Femoral Artery (SPACIAL)
Recruitment status was: Recruiting
|Arterial Occlusive Diseases Vascular Diseases||Device: stent Device: femoral-popliteal bypass with artificial blood vessel||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Study to Compare the Treatment of Stent and Prothesis Bypass in SFA Occlusions|
- Occlusion of the stent or artificial blood vessel bypass [ Time Frame: 36 months ]
- Mortality [ Time Frame: 30 days ]The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure.
- Rate of limb salvage [ Time Frame: 36 months ]
- Procedural complications, defined as any adverse event [ Time Frame: 36 months ]including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula
- Quality of Life assessment [ Time Frame: 36 months ]assessment in 1 month,6 months,12 months,24 months and 36 months post procedure
- Rate of amputation [ Time Frame: 36 months ]
- Increase in Ankle Brachial Index [ Time Frame: 36 months ]
- Restenosis measured by Duplex Ultrasound or CTA [ Time Frame: 36 months ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Patients presenting with long occlusion of the superficial femoral artery enrolled in bypass arm will undergo suprageniculate femoropopliteal bypass surgery to bypass the occluded superficial femoral artery. And the graft will be artificial blood vessel.
Device: femoral-popliteal bypass with artificial blood vessel
Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.
Before operation, take aspirin 100mg every day. During the operation, stent is delivered by a catheter and positioned through the narrowing in the artery. The stent is then expanded against the wall of the blood vessel to provide a wider channel for blood. At last, use balloon dilate the stent.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01147419
|Contact: Liu Changwei, firstname.lastname@example.org|
|Contact: Ye Wei, email@example.com|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100032|
|Contact: Liu Changwei, bachelor 86-010-88068230 firstname.lastname@example.org|
|Contact: Ye Wei, doctor 86-010-88068230 email@example.com|
|Principal Investigator: Ye Wei, doctor|
|Sub-Investigator: Chen Yu, doctor|
|Sub-Investigator: Wu Weiwei, doctor|
|Xuanwu Hospital, Beijing||Recruiting|
|Beijing, Beijing, China, 100053|
|Contact: Gu Yongquan, doctor|
|Principal Investigator: Gu Yongquan, doctor|
|Beijing Tongren Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Yu Zhengya, doctor firstname.lastname@example.org|
|Principal Investigator: Yu Zhengya, doctor|
|Study Chair:||Liu Changwei, bachelor|
|Principal Investigator:||Ye Wei, doctor|