Comparison of Stent and Prothesis Bypass in Superficial Femoral Artery

Vascular Diseases Clinical Trial

— SPACIAL  

Official title:

The Study to Compare the Treatment of Stent and Prothesis Bypass in SFA Occlusions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01147419
• Other study ID #: pumch-vascular surgery
• Status: Recruiting
• Phase: Phase 4
• First received: June 16, 2010
• Last updated: July 6, 2010
• Start date: June 2010
• Est. completion date: June 2015

Study information

• Verified date: July 2010
• Source: Peking Union Medical College Hospital
• Contact: Liu Changwei, bachelor
• Phone: 86-010-88068230
• Email: liucw[@]vip.sina.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2015
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Vascular Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Xuanwu Hospital, Beijing	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Beijing Tongren Hospital, Xuanwu Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occlusion of the stent or artificial blood vessel bypass		36 months	No
Secondary	Mortality	The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure.	30 days	Yes
Secondary	Rate of limb salvage		36 months	Yes
Secondary	Procedural complications, defined as any adverse event	including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula	36 months	Yes
Secondary	Quality of Life assessment	assessment in 1 month,6 months,12 months,24 months and 36 months post procedure	36 months	No
Secondary	Rate of amputation		36 months	No
Secondary	Increase in Ankle Brachial Index		36 months	No
Secondary	Restenosis measured by Duplex Ultrasound or CTA		36 months	Yes

External Links

•   the website of the vascular surgery department of PUMCH