Atherosclerotic Lesions of the Common Femoral Artery
Conditions
Brief 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.
Interventions
DEVICEEndovascular treatment using self expandable nitinol STENTS
A direct stenting will be performed.
DEVICEOpen repair treatment
The surgeon will perform its usual technique to revascularize the common femoral artery
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age between 40 and 90 years-old * De novo atheromatous common femoral artery stenosis * Symptomatic lesions (Rutherford stages 3, 4, 5 and 6) * Haemodynamically significant lesion * Written informed consent
Exclusion criteria
* Restenosis * Non-atheromatous lesions (dysplasia, post-traumatic, inflammatory) * external iliac thrombosis and / or common femoral side to treat * Contraindication to open surgery or endovascular treatment * Contraindication to anesthesia * Indication of aorto-femoral, ilio-femoral, femoral-popliteal or femoro-tibialis bypass to associate with the common femoral revascularization * Indication of a surgical approach to the external iliac artery through a retroperitoneal * Asymptomatic lesions * Life expectancy less than one year * Refusing patient * Inability to monitor during the test period * Participation in another clinical trial * Pregnant Women * No written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Morbid-mortality rate at 30 days | 30 days | Morbid-mortality rate is defined by: Death, general complications and local complications requiring re-admission and / or reoperation. |
Secondary
| Measure | Time frame |
|---|---|
| Technical success | 1 month |
| Hospital length of stay | 1 month |
| Primary sustained clinical improvement | 1 month |
| Target lesion revascularization | 1 month |
| In-stent restenosis | 1 month |
| Stent fracture | 1 month |
| Secondary sustained clinical improvement | 1 month |
| Target extremity revascularization | 1 month |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORYann GOUEFFIC, Doctor
Nantes University Hospital
Outcome results
None listed