Endovascular Versus Open Repair of the Common Femoral Artery

Study Overview
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Brief Summary
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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.

Official Title
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Endovascular Versus Open Repair of the Common Femoral Artery: a Randomized Trial (TECCO)

Conditions
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Atherosclerotic Lesions of the Common Femoral Artery

Intervention / Treatment
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* Device: Endovascular treatment using self expandable nitinol STENTS
* Device: Open repair treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endovascular treatment<br> | Device: Endovascular treatment using self expandable nitinol STENTS<br>* A direct stenting will be performed.<br>|
| Active Comparator: Open repair treatment<br> | Device: Open repair treatment<br>* The surgeon will perform its usual technique to revascularize the common femoral artery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success |  | 1 month | 
| Hospital length of stay |  | 1 month | 
| Primary sustained clinical improvement |  | 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 |