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

Primary Purpose

Arterial Occlusive Diseases, Vascular Diseases

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
stent
femoral-popliteal bypass with artificial blood vessel
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Occlusive Diseases focused on measuring critical limb ischemia, peripheral artery occlusive disease, femoropopliteal artery bypass, Stent

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting
  • Xuanwu Hospital, BeijingRecruiting
  • Beijing Tongren HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

bypass

stent

Arm Description

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.

Outcomes

Primary Outcome Measures

Occlusion of the stent or artificial blood vessel bypass

Secondary Outcome Measures

Mortality
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
Procedural complications, defined as any adverse event
including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula
Quality of Life assessment
assessment in 1 month,6 months,12 months,24 months and 36 months post procedure
Rate of amputation
Increase in Ankle Brachial Index
Restenosis measured by Duplex Ultrasound or CTA

Full Information

First Posted
June 16, 2010
Last Updated
July 6, 2010
Sponsor
Peking Union Medical College Hospital
Collaborators
Beijing Tongren Hospital, Xuanwu Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT01147419
Brief Title
Comparison of Stent and Prothesis Bypass in Superficial Femoral Artery
Acronym
SPACIAL
Official Title
The Study to Compare the Treatment of Stent and Prothesis Bypass in SFA Occlusions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Beijing Tongren Hospital, Xuanwu Hospital, Beijing

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Occlusive Diseases, Vascular Diseases
Keywords
critical limb ischemia, peripheral artery occlusive disease, femoropopliteal artery bypass, Stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bypass
Arm Type
Experimental
Arm Description
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.
Arm Title
stent
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
stent
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
femoral-popliteal bypass with artificial blood vessel
Intervention Description
Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.
Primary Outcome Measure Information:
Title
Occlusion of the stent or artificial blood vessel bypass
Time Frame
36 months
Secondary Outcome Measure Information:
Title
Mortality
Description
The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure.
Time Frame
30 days
Title
Rate of limb salvage
Time Frame
36 months
Title
Procedural complications, defined as any adverse event
Description
including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula
Time Frame
36 months
Title
Quality of Life assessment
Description
assessment in 1 month,6 months,12 months,24 months and 36 months post procedure
Time Frame
36 months
Title
Rate of amputation
Time Frame
36 months
Title
Increase in Ankle Brachial Index
Time Frame
36 months
Title
Restenosis measured by Duplex Ultrasound or CTA
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liu Changwei, bachelor
Phone
86-010-88068230
Email
liucw@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ye Wei, doctor
Phone
86-010-88068230
Email
yewill18@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Changwei, bachelor
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ye Wei, doctor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Changwei, bachelor
Phone
86-010-88068230
Email
liucw@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Ye Wei, doctor
Phone
86-010-88068230
Email
yewill18@gmail.com
First Name & Middle Initial & Last Name & Degree
Ye Wei, doctor
First Name & Middle Initial & Last Name & Degree
Chen Yu, doctor
First Name & Middle Initial & Last Name & Degree
Wu Weiwei, doctor
Facility Name
Xuanwu Hospital, Beijing
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gu Yongquan, doctor
First Name & Middle Initial & Last Name & Degree
Gu Yongquan, doctor
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Zhengya, doctor
Email
zhengyayu@yahoo.com
First Name & Middle Initial & Last Name & Degree
Yu Zhengya, doctor

12. IPD Sharing Statement

Links:
URL
http://www.vascular.cn/
Description
the website of the vascular surgery department of PUMCH

Learn more about this trial

Comparison of Stent and Prothesis Bypass in Superficial Femoral Artery

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