Endovascular Versus Open Repair of the Common Femoral Artery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2015-09-30

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.

Detailed Description

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Conditions

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Atherosclerotic Lesions of the Common Femoral Artery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endovascular treatment

Group Type EXPERIMENTAL

Endovascular treatment using self expandable nitinol STENTS

Intervention Type DEVICE

A direct stenting will be performed.

Open repair treatment

Group Type ACTIVE_COMPARATOR

Open repair treatment

Intervention Type DEVICE

The surgeon will perform its usual technique to revascularize the common femoral artery

Interventions

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Endovascular treatment using self expandable nitinol STENTS

A direct stenting will be performed.

Intervention Type DEVICE

Open repair treatment

The surgeon will perform its usual technique to revascularize the common femoral artery

Intervention Type DEVICE

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yann GOUEFFIC, Doctor

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

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France

References

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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.

Reference Type DERIVED

PMID: 28683941 (View on PubMed)

Other Identifiers

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10/6-Q

Identifier Type: -

Identifier Source: org_study_id

Endovascular Versus Open Repair of the Common Femoral Artery

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Study Design

Study Groups

Endovascular treatment

Endovascular treatment using self expandable nitinol STENTS

Open repair treatment

Open repair treatment

Interventions

Endovascular treatment using self expandable nitinol STENTS

Open repair treatment

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Nantes University Hospital

Responsible Party

Principal Investigators

Yann GOUEFFIC, Doctor

Locations

University Hospital

University Hospital

University Hospital

University Hospital

University Hospital

University Hospital

University Hospital

NCN Clinic

St Augustin Clinic

University Hospital

University Hospital

University Hospital, HEGP

University Hospital, Henri Mondor

University Hospital

University Hospital

University Hospital

Tonkin Clinic

Countries

References

Other Identifiers

10/6-Q