Endovascular Versus Open Repair of the Common Femoral Artery

Phase 4

Completed

• Conditions: Atherosclerotic Lesions of the Common Femoral Artery
• Interventions: Device: Endovascular treatment using self expandable nitinol STENTS; Device: Open repair treatment

• Registration Number: NCT01353651
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-05-09
• Study First Submitted QC: 2011-05-11
• Study First Posted: 2011-05-13
• Primary Completion: 2013-10
• Study Completion: 2015-09
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-22
• Last Update Posted: 2015-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endovascular treatment	Endovascular treatment using self expandable nitinol STENTS	-
Open repair treatment	Open repair treatment	-

Primary Outcome Measures

Name	Time	Method
Morbid-mortality rate at 30 days	30 days	Morbid-mortality rate is defined by: Death, general complications and local complications requiring re-admission and / or reoperation.

Secondary Outcome Measures

Name	Time	Method
Technical success	1 month
Hospital length of stay	1 month
Primary sustained clinical improvement	24 months
Target lesion revascularization	24 months
In-stent restenosis	24 months
Stent fracture	24 months
Secondary sustained clinical improvement	24 months
Target extremity revascularization	24 months

Trial Locations

Locations (6)

University Hospital; 🇫🇷 Strasbourg, France

St Augustin Clinic; 🇫🇷 Nantes, France

University Hospital, HEGP; 🇫🇷 Paris, France

University Hospital, Henri Mondor; 🇫🇷 Paris, France

NCN Clinic; 🇫🇷 Nantes, France

Tonkin Clinic; 🇫🇷 Villeurbanne, France