Comparison of Stent and Prothesis Bypass in Superficial Femoral Artery (SPACIAL)

July 6, 2010 updated by: Peking Union Medical College Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ye Wei, doctor
        • Sub-Investigator:
          • Chen Yu, doctor
        • Sub-Investigator:
          • Wu Weiwei, doctor
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Beijing Tongren Hospital
        • Contact:
        • Principal Investigator:
          • Yu Zhengya, doctor
      • Beijing, Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital, Beijing
        • Contact:
          • Gu Yongquan, doctor
        • Principal Investigator:
          • Gu Yongquan, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occlusion of the stent or artificial blood vessel bypass
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days
Rate of limb salvage
Time Frame: 36 months
36 months
Procedural complications, defined as any adverse event
Time Frame: 36 months
including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula
36 months
Quality of Life assessment
Time Frame: 36 months
assessment in 1 month,6 months,12 months,24 months and 36 months post procedure
36 months
Rate of amputation
Time Frame: 36 months
36 months
Increase in Ankle Brachial Index
Time Frame: 36 months
36 months
Restenosis measured by Duplex Ultrasound or CTA
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Xuanwu Hospital, Beijing
Beijing Tongren Hospital

Investigators

  • Principal Investigator: Ye Wei, doctor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ANTICIPATED)

June 1, 2012

Study Completion (ANTICIPATED)

June 1, 2015

Study Registration Dates

First Submitted

June 16, 2010

First Submitted That Met QC Criteria

June 17, 2010

First Posted (ESTIMATE)

June 22, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 7, 2010

Last Update Submitted That Met QC Criteria

July 6, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • pumch-vascular surgery

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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