Endovascular Versus Open Repair of the Common Femoral Artery

NCT01353651 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-12-23

No results posted yet for this study

Summary

Even though the indication for endovascular therapy has been enlarged, open repair of common femoral artery is still considered as the treatment of choice. A recent pilot study showed that endovascular repair of the CFA seems to be a safe technique of revascularization with acceptable initial results at 12 months (Azema et al, Eur J Vasc Endovasc Surg, 2011, in press). TECCO, a French randomized and controlled trial, has been set up to compare open and endovascular procedures for the treatment of CFA atherosclerotic lesions.

Conditions

  • Atherosclerotic Lesions of the Common Femoral Artery

Interventions

DEVICE

Endovascular treatment using self expandable nitinol STENTS

A direct stenting will be performed.

DEVICE

Open repair treatment

The surgeon will perform its usual technique to revascularize the common femoral artery

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Yann GOUEFFIC, Doctor · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-10-31
Completion
2015-09-30

Countries

  • France

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 NCT01353651 on ClinicalTrials.gov