Comparison of Stent and Prothesis Bypass in Superficial Femoral Artery (SPACIAL)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Arterial Occlusive Diseases Vascular Diseases |
Device: stent Device: femoral-popliteal bypass with artificial blood vessel |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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 ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
- Procedural complications, defined as any adverse event [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula
- Quality of Life assessment [ Time Frame: 36 months ] [ Designated as safety issue: No ]assessment in 1 month,6 months,12 months,24 months and 36 months post procedure
- Rate of amputation [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Increase in Ankle Brachial Index [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Restenosis measured by Duplex Ultrasound or CTA [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: bypass
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.
|
| Experimental: stent |
Device: stent
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 45 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The patients volunteer to join the trial and sign the formal consent.
- The patients are ≥45 year-old and ≤80 year-old.
- The patients suffer from symptomatic leg ischemia with rutherford classification3, 4 , 5 or 6. The presentation is severe intermittent claudication, rest pain, ulcer or gangrene.
- The total length of the femoral and popliteal artery lesion(including ≥75% stenosis and occlusion) are at least 15cm.
- The femoral-popliteal artery has never received bypass or endovascular therapy before.
- No obvious stenosis or occlusion in the aortoiliac artery; or the lesion could be treated simultaneously or has already been cured.
- No obvious stenosis in below-knee popliteal artery; at least 1 vessel infra-popliteal runoff to the foot.
- No surgical contraindications;no infection in operation region.
- No available saphenous vein.
Exclusion Criteria:
- Refuse random treatment.
- Previous operations on the superficial femoral artery.
- Acute lower extremity arterial thrombosis.
- Serious major organ failure.
- Allergic to the contrast agent or has contrast nephropathy.
- No clinical compliance or unfit to join the trial.
Contacts and Locations| Contact: Liu Changwei, bachelor | 86-010-88068230 | liucw@vip.sina.com |
| Contact: Ye Wei, doctor | 86-010-88068230 | yewill18@gmail.com |
| China, Beijing | |
| Peking Union Medical College Hospital | Recruiting |
| Beijing, Beijing, China, 100032 | |
| Contact: Liu Changwei, bachelor 86-010-88068230 liucw@vip.sina.com | |
| Contact: Ye Wei, doctor 86-010-88068230 yewill18@gmail.com | |
| Principal Investigator: Ye Wei, doctor | |
| Sub-Investigator: Chen Yu, doctor | |
| Sub-Investigator: Wu Weiwei, doctor | |
| Beijing Tongren Hospital | Recruiting |
| Beijing, Beijing, China, 100730 | |
| Contact: Yu Zhengya, doctor zhengyayu@yahoo.com | |
| Principal Investigator: Yu Zhengya, doctor | |
| Xuanwu Hospital, Beijing | Recruiting |
| Beijing, Beijing, China, 100053 | |
| Contact: Gu Yongquan, doctor | |
| Principal Investigator: Gu Yongquan, doctor | |
| Study Chair: | Liu Changwei, bachelor | |
| Principal Investigator: | Ye Wei, doctor |
More Information
Additional Information:
No publications provided
| Responsible Party: | Liu Changwei, the department of vascular surgery of PUMCH |
| ClinicalTrials.gov Identifier: | NCT01147419 History of Changes |
| Other Study ID Numbers: | pumch-vascular surgery |
| Study First Received: | June 16, 2010 |
| Last Updated: | July 6, 2010 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Peking Union Medical College Hospital:
|
critical limb ischemia peripheral artery occlusive disease femoropopliteal artery bypass Stent |
Additional relevant MeSH terms:
|
Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Blood Substitutes |
Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013