Endovascular Versus Open Repair of the Common Femoral Artery (TECCO)

Nantes University Hospital (NUH)

Status and phase

Completed

Phase 4

Conditions

Atherosclerotic Lesions of the Common Femoral Artery

Treatments

Device: Open repair treatment

Device: Endovascular treatment using self expandable nitinol STENTS

Study type

Interventional

Funder types

Other

Identifiers

NCT01353651

10/6-Q

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

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