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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
A direct stenting will be performed.
The surgeon will perform its usual technique to revascularize the common femoral artery
University Hospital
Amiens, France
University Hospital
Besançon, France
University Hospital
Bordeaux, France
Morbid-mortality rate at 30 days
Morbid-mortality rate is defined by: Death, general complications and local complications requiring re-admission and / or reoperation.
Time frame: 30 days
Technical success
Time frame: 1 month
Hospital length of stay
Time frame: 1 month
Primary sustained clinical improvement
Time frame: 1 month
Primary sustained clinical improvement
Time frame: 6 months
Primary sustained clinical improvement
Time frame: 12 months
Primary sustained clinical improvement
Time frame: 24 months
Target lesion revascularization
Time frame: 1 month
Target lesion revascularization
Time frame: 6 months
Target lesion revascularization
Time frame: 12 months
Target lesion revascularization
Time frame: 24 months
In-stent restenosis
Time frame: 1 month
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University Hospital
Clermont-Ferrand, France
University Hospital
Dijon, France
University Hospital
Lyon, France
University Hospital
Marseille, France
NCN Clinic
Nantes, France
St Augustin Clinic
Nantes, France
University Hospital
Nantes, France
...and 7 more locations
In-stent restenosis
Time frame: 6 months
In-stent restenosis
Time frame: 12 months
In-stent restenosis
Time frame: 24 months
Stent fracture
Time frame: 1 month
Stent fracture
Time frame: 6 months
Stent fracture
Time frame: 12 months
Stent fracture
Time frame: 24 months
Secondary sustained clinical improvement
Time frame: 1 month
Secondary sustained clinical improvement
Time frame: 6 months
Secondary sustained clinical improvement
Time frame: 12 months
Secondary sustained clinical improvement
Time frame: 24 months
Target extremity revascularization
Time frame: 1 month
Target extremity revascularization
Time frame: 6 months
Target extremity revascularization
Time frame: 12 months
Target extremity revascularization
Time frame: 24 months