Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endovascular treatment | Experimental |
| |
| Open repair treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular treatment using self expandable nitinol STENTS | Device | A direct stenting will be performed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Morbid-mortality rate at 30 days | Morbid-mortality rate is defined by: Death, general complications and local complications requiring re-admission and / or reoperation. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | 1 month | |
| Hospital length of stay | 1 month | |
| Primary sustained clinical improvement |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yann GOUEFFIC, Doctor | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Amiens | France | ||||
| University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28683941 | Derived | Goueffic Y, Della Schiava N, Thaveau F, Rosset E, Favre JP, Salomon du Mont L, Alsac JM, Hassen-Khodja R, Reix T, Allaire E, Ducasse E, Soler R, Guyomarc'h B, Nasr B. Stenting or Surgery for De Novo Common Femoral Artery Stenosis. JACC Cardiovasc Interv. 2017 Jul 10;10(13):1344-1354. doi: 10.1016/j.jcin.2017.03.046. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Open repair treatment | Device | The surgeon will perform its usual technique to revascularize the common femoral artery |
|
| 1 month |
| Primary sustained clinical improvement | 6 months |
| Primary sustained clinical improvement | 12 months |
| Primary sustained clinical improvement | 24 months |
| Target lesion revascularization | 1 month |
| Target lesion revascularization | 6 months |
| Target lesion revascularization | 12 months |
| Target lesion revascularization | 24 months |
| In-stent restenosis | 1 month |
| In-stent restenosis | 6 months |
| In-stent restenosis | 12 months |
| In-stent restenosis | 24 months |
| Stent fracture | 1 month |
| Stent fracture | 6 months |
| Stent fracture | 12 months |
| Stent fracture | 24 months |
| Secondary sustained clinical improvement | 1 month |
| Secondary sustained clinical improvement | 6 months |
| Secondary sustained clinical improvement | 12 months |
| Secondary sustained clinical improvement | 24 months |
| Target extremity revascularization | 1 month |
| Target extremity revascularization | 6 months |
| Target extremity revascularization | 12 months |
| Target extremity revascularization | 24 months |
| Besançon |
| France |
| University Hospital | Bordeaux | France |
| 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 |
| University Hospital | Nice | France |
| University Hospital, HEGP | Paris | France |
| University Hospital, Henri Mondor | Paris | France |
| University Hospital | Rouen | France |
| University Hospital | Saint-Etienne | France |
| University Hospital | Strasbourg | France |
| Tonkin Clinic | Villeurbanne | France |