Endovascular Versus Open Repair of the Common Femoral Artery (TECCO)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01353651
First received: May 9, 2011
Last updated: September 18, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Atherosclerotic Lesions of the Common Femoral Artery
Device: Endovascular treatment using self expandable nitinol STENTS
Device: Open repair treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endovascular Versus Open Repair of the Common Femoral Artery: a Randomized Trial (TECCO)

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Morbid-mortality rate at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Morbid-mortality rate is defined by: Death, general complications and local complications requiring re-admission and / or reoperation.


Secondary Outcome Measures:
  • Technical success [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Primary sustained clinical improvement [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Primary sustained clinical improvement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Primary sustained clinical improvement [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Primary sustained clinical improvement [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Target lesion revascularization [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Target lesion revascularization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Target lesion revascularization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Target lesion revascularization [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • In-stent restenosis [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • In-stent restenosis [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • In-stent restenosis [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • In-stent restenosis [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Stent fracture [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Stent fracture [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Stent fracture [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Stent fracture [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Secondary sustained clinical improvement [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Secondary sustained clinical improvement [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Secondary sustained clinical improvement [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Secondary sustained clinical improvement [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Target extremity revascularization [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Target extremity revascularization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Target extremity revascularization [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Target extremity revascularization [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: February 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endovascular treatment Device: Endovascular treatment using self expandable nitinol STENTS
A direct stenting will be performed.
Active Comparator: Open repair treatment Device: Open repair treatment
The surgeon will perform its usual technique to revascularize the common femoral artery

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353651

Locations
France
University Hospital
Amiens, France
University Hospital
Besançon, France
University Hospital
Bordeaux, France
University Hospital
Clermont-Ferrand, France
University Hospital
Dijon, France
University Hospital
Lyon, France
University Hospital
Marseille, France
St Augustin Clinic
Nantes, France
NCN 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
St Etienne, France
University Hospital
Strasbourg, France
Tonkin Clinic
Villeurbanne, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Yann GOUEFFIC, Doctor Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01353651     History of Changes
Other Study ID Numbers: 10/6-Q
Study First Received: May 9, 2011
Last Updated: September 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on August 01, 2014