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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2010 by Peking Union Medical College Hospital
Sponsor:
Collaborators:
Beijing Tongren Hospital
Xuanwu Hospital, Beijing
Information provided by:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01147419
First received: June 16, 2010
Last updated: July 6, 2010
Last verified: July 2010
  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

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Occlusion of the stent or artificial blood vessel bypass [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01147419

Contacts
Contact: Liu Changwei, bachelor 86-010-88068230 liucw@vip.sina.com
Contact: Ye Wei, doctor 86-010-88068230 yewill18@gmail.com

Locations
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         
Sponsors and Collaborators
Peking Union Medical College Hospital
Beijing Tongren Hospital
Xuanwu Hospital, Beijing
Investigators
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 July 22, 2014