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CompletedNCT01353651TECCOUpdated Sep 14, 2026

Endovascular Versus Open Repair of the Common Femoral Artery

A Phase 4 interventional study of Endovascular treatment using self expandable nitinol STENTS and Open repair treatment in Atherosclerotic Lesions of the Common Femoral Artery, sponsored by Nantes University Hospital. Completed at 17 sites in France. Open to participants aged 40 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Nantes University Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
40 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Atherosclerotic Lesions of the Common Femoral Artery
03

In context

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • Experimental
    Endovascular treatment

    Device: Endovascular treatment using self expandable nitinol STENTS

  • Active comparator
    Open repair treatment

    Device: Open repair treatment

Interventions

  • DeviceEndovascular treatment using self expandable nitinol STENTS

    A direct stenting will be performed.

  • DeviceOpen repair treatment

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

06

What researchers measure

Primary outcomes

  1. Morbid-mortality rate at 30 days

    Morbid-mortality rate is defined by: Death, general complications and local complications requiring re-admission and / or reoperation.

    Time frame: 30 days

Secondary outcomes

  1. Technical success

    Time frame: 1 month

  2. Hospital length of stay

    Time frame: 1 month

  3. Primary sustained clinical improvement

    Time frame: 1 month

  4. Primary sustained clinical improvement

    Time frame: 6 months

  5. Primary sustained clinical improvement

    Time frame: 12 months

  6. Primary sustained clinical improvement

    Time frame: 24 months

  7. Target lesion revascularization

    Time frame: 1 month

  8. Target lesion revascularization

    Time frame: 6 months

  9. Target lesion revascularization

    Time frame: 12 months

  10. Target lesion revascularization

    Time frame: 24 months

  11. In-stent restenosis

    Time frame: 1 month

  12. In-stent restenosis

    Time frame: 6 months

  13. In-stent restenosis

    Time frame: 12 months

  14. In-stent restenosis

    Time frame: 24 months

  15. Stent fracture

    Time frame: 1 month

  16. Stent fracture

    Time frame: 6 months

  17. Stent fracture

    Time frame: 12 months

  18. Stent fracture

    Time frame: 24 months

  19. Secondary sustained clinical improvement

    Time frame: 1 month

  20. Secondary sustained clinical improvement

    Time frame: 6 months

  21. Secondary sustained clinical improvement

    Time frame: 12 months

  22. Secondary sustained clinical improvement

    Time frame: 24 months

  23. Target extremity revascularization

    Time frame: 1 month

  24. Target extremity revascularization

    Time frame: 6 months

  25. Target extremity revascularization

    Time frame: 12 months

  26. Target extremity revascularization

    Time frame: 24 months

07

Study locations

17 sites
  • 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
  • NCN Clinic
    Nantes, France
  • St Augustin 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
    Saint-Etienne, France
  • University Hospital
    Strasbourg, France
  • Tonkin Clinic
    Villeurbanne, France
08

References and documents

Publications

  • 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. PubMed 28683941 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01353651
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
May 13, 2011
Start date
Feb 2011
Primary completion
Oct 2013
Completion
Sep 2015
Last update
Sep 14, 2026

Study contacts

Yann GOUEFFIC, Doctor
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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