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Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part I) (DCLI-I)

Primary Purpose

Vascular Diseases, Diabetes

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

About this trial

This is an interventional treatment trial for Vascular Diseases focused on measuring Critical limb ischemia, Diabetes, Femoropopliteal artery bypass, Stent

Eligibility Criteria

55 Years - 75 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 ≥55 year-old and ≤75 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 lesion of the femoral artery should be TASC B、C or D.
  • 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.
  • Be diagnosed with DM for at least 1 year.

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 Hospital
  • Xuanwu Hospital, Beijing
  • Beijing Tongren Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

bypass

stent

Arm Description

femoral-popliteal bypass

Outcomes

Primary Outcome Measures

Occlusion of the stent or 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
Restenosis measured by Duplex Ultrasound or CTA

Full Information

First Posted
July 26, 2010
Last Updated
December 20, 2012
Sponsor
Peking Union Medical College Hospital
Collaborators
Beijing Tongren Hospital, Xuanwu Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT01171703
Brief Title
Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part I)
Acronym
DCLI-I
Official Title
Optimized Strategy for Diabetic Patients With Critical Limb Ischemia: A Multi-center, Randomized Controlled Trial and Registration Study(Part I)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
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
The purpose of this trial is to find out the appropriate way to treat DM patients with critical limb ischemia. This trial includes two parts. Part I focuses on the treatment of femoral arterial lesion and part II focuses on the treatment of below-knee arterial lesion.
Detailed Description
The trial includes two parts and here is part I. This part is a multi-center, prospective, randomized, controlled study to compare the therapeutic effect of stent and bypass to chronic long occlusion of the superficial femoral artery in DM patients. Totally 70 patients will be entered into the study. The lesion of the femoral artery should be TASC B、C or D and the patients should suffered ischemic symptom with 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vascular Diseases, Diabetes
Keywords
Critical limb ischemia, Diabetes, 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
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
bypass
Arm Type
Experimental
Arm Description
femoral-popliteal bypass
Arm Title
stent
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
femoral-popliteal bypass
Intervention Description
Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.
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.
Primary Outcome Measure Information:
Title
Occlusion of the stent or 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
Restenosis measured by Duplex Ultrasound or CTA
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patients volunteer to join the trial and sign the formal consent. The patients are ≥55 year-old and ≤75 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 lesion of the femoral artery should be TASC B、C or D. 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. Be diagnosed with DM for at least 1 year. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu changwei, bachelor
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Xuanwu Hospital, Beijing
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100053
Country
China
Facility Name
Beijing Tongren Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China

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

Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part I)

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