NCT01171703

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_4

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 26, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 24, 2012

Status Verified

July 1, 2010

Enrollment Period

2.7 years

First QC Date

July 26, 2010

Last Update Submit

December 20, 2012

Conditions

Vascular DiseasesDiabetes

Keywords

Critical limb ischemiaDiabetesFemoropopliteal artery bypassStent

Outcome Measures

Primary Outcomes (1)

  • Occlusion of the stent or bypass

    36 months

Secondary Outcomes (5)

  • Mortality

    30 days

  • Rate of limb salvage

    36 months

  • Procedural complications, defined as any adverse event

    36 months

  • Quality of Life assessment

    36 months

  • Restenosis measured by Duplex Ultrasound or CTA

    36 months

Study Arms (2)

bypass

EXPERIMENTAL

femoral-popliteal bypass

Device: femoral-popliteal bypass

stent

EXPERIMENTAL
Device: stent

Interventions

femoral-popliteal bypassDEVICE

Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.

bypass
stentDEVICE

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.

stent

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Location

Xuanwu Hospital, Beijing

Beijing, Beijing Municipality, 100053, China

Location

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Links

MeSH Terms

Conditions

Vascular DiseasesDiabetes MellitusChronic Limb-Threatening Ischemia

Interventions

Stents

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPeripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Officials

  • Liu changwei, bachelor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vascular Surgery

Study Record Dates

First Submitted

July 26, 2010

First Posted

July 28, 2010

Study Start

November 1, 2010

Primary Completion

July 1, 2013

Study Completion

July 1, 2016

Last Updated

December 24, 2012

Record last verified: 2010-07

Locations

CN(3)