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Comparison of Stent and Prothesis Bypass in Superficial Femoral Artery

NCT01147419 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2010-07-07

No results posted yet for this study

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.

Conditions

  • Arterial Occlusive Diseases
  • Vascular Diseases

Interventions

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.

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.

Sponsors & Collaborators

  • Beijing Tongren Hospital

    collaborator OTHER

  • Xuanwu Hospital, Beijing

    collaborator OTHER

  • Peking Union Medical College Hospital

    lead OTHER

Principal Investigators

  • Liu Changwei, bachelor

  • Ye Wei, doctor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2012-06-30
Completion
2015-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01147419 on ClinicalTrials.gov