Clinical trial NCT01353651: Endovascular Versus Open Repair of the Common Femoral Artery
Official title: Endovascular Versus Open Repair of the Common Femoral Artery: a Randomized Trial (TECCO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Atherosclerotic Lesions of the Common Femoral Artery
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2011-05-13
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Morbid-mortality rate at 30 days
timeFrame: 30 days
Secondary outcomes:
measure: Technical success
timeFrame: 1 month
measure: Hospital length of stay
timeFrame: 1 month
measure: Primary sustained clinical improvement
timeFrame: 1 month
measure: Primary sustained clinical improvement
timeFrame: 6 months
measure: Primary sustained clinical improvement
timeFrame: 12 months
measure: Primary sustained clinical improvement
timeFrame: 24 months
measure: Target lesion revascularization
timeFrame: 1 month
measure: Target lesion revascularization
timeFrame: 6 months
measure: Target lesion revascularization
timeFrame: 12 months
measure: Target lesion revascularization
timeFrame: 24 months
measure: In-stent restenosis
timeFrame: 1 month
measure: In-stent restenosis
timeFrame: 6 months
measure: In-stent restenosis
timeFrame: 12 months
measure: In-stent restenosis
timeFrame: 24 months
measure: Stent fracture
timeFrame: 1 month
measure: Stent fracture
timeFrame: 6 months
measure: Stent fracture
timeFrame: 12 months
measure: Stent fracture
timeFrame: 24 months
measure: Secondary sustained clinical improvement
timeFrame: 1 month
measure: Secondary sustained clinical improvement
timeFrame: 6 months
measure: Secondary sustained clinical improvement
timeFrame: 12 months
measure: Secondary sustained clinical improvement
timeFrame: 24 months
measure: Target extremity revascularization
timeFrame: 1 month
measure: Target extremity revascularization
timeFrame: 6 months
measure: Target extremity revascularization
timeFrame: 12 months
measure: Target extremity revascularization
timeFrame: 24 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: University Hospital
city: Besançon
country: France
facility: University Hospital
city: Bordeaux
country: France
facility: University Hospital
city: Clermont-Ferrand
country: France
facility: University Hospital
city: Dijon
country: France
facility: University Hospital
city: Lyon
country: France
facility: University Hospital
city: Marseille
country: France
facility: University Hospital
city: Nantes
country: France
facility: NCN Clinic
city: Nantes
country: France
facility: St Augustin Clinic
city: Nantes
country: France
facility: University Hospital
city: Nice
country: France
facility: University Hospital
city: Paris
country: France
facility: University Hospital, HEGP
city: Paris
country: France
facility: University Hospital, Henri Mondor
city: Rouen
country: France
facility: University Hospital
city: St Etienne
country: France
facility: University Hospital
city: Strasbourg
country: France
facility: University Hospital
city: Villeurbanne
country: France
facility: Tonkin Clinic
Study officials:
affiliation: Nantes University Hospital
name: Yann GOUEFFIC, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.