Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT01353651
Status:
COMPLETED
Last Update Posted:
2015-12-23
First Post:
2011-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endovascular Versus Open Repair of the Common Femoral Artery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-22', 'studyFirstSubmitDate': '2011-05-09', 'studyFirstSubmitQcDate': '2011-05-11', 'lastUpdatePostDateStruct': {'date': '2015-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morbid-mortality rate at 30 days', 'timeFrame': '30 days', 'description': 'Morbid-mortality rate is defined by: Death, general complications and local complications requiring re-admission and / or reoperation.'}], 'secondaryOutcomes': [{'measure': 'Technical success', 'timeFrame': '1 month'}, {'measure': 'Hospital length of stay', 'timeFrame': '1 month'}, {'measure': 'Primary sustained clinical improvement', 'timeFrame': '1 month'}, {'measure': 'Primary sustained clinical improvement', 'timeFrame': '6 months'}, {'measure': 'Primary sustained clinical improvement', 'timeFrame': '12 months'}, {'measure': 'Primary sustained clinical improvement', 'timeFrame': '24 months'}, {'measure': 'Target lesion revascularization', 'timeFrame': '1 month'}, {'measure': 'Target lesion revascularization', 'timeFrame': '6 months'}, {'measure': 'Target lesion revascularization', 'timeFrame': '12 months'}, {'measure': 'Target lesion revascularization', 'timeFrame': '24 months'}, {'measure': 'In-stent restenosis', 'timeFrame': '1 month'}, {'measure': 'In-stent restenosis', 'timeFrame': '6 months'}, {'measure': 'In-stent restenosis', 'timeFrame': '12 months'}, {'measure': 'In-stent restenosis', 'timeFrame': '24 months'}, {'measure': 'Stent fracture', 'timeFrame': '1 month'}, {'measure': 'Stent fracture', 'timeFrame': '6 months'}, {'measure': 'Stent fracture', 'timeFrame': '12 months'}, {'measure': 'Stent fracture', 'timeFrame': '24 months'}, {'measure': 'Secondary sustained clinical improvement', 'timeFrame': '1 month'}, {'measure': 'Secondary sustained clinical improvement', 'timeFrame': '6 months'}, {'measure': 'Secondary sustained clinical improvement', 'timeFrame': '12 months'}, {'measure': 'Secondary sustained clinical improvement', 'timeFrame': '24 months'}, {'measure': 'Target extremity revascularization', 'timeFrame': '1 month'}, {'measure': 'Target extremity revascularization', 'timeFrame': '6 months'}, {'measure': 'Target extremity revascularization', 'timeFrame': '12 months'}, {'measure': 'Target extremity revascularization', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atherosclerotic Lesions of the Common Femoral Artery']}, 'referencesModule': {'references': [{'pmid': '28683941', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 40 and 90 years-old\n* De novo atheromatous common femoral artery stenosis\n* Symptomatic lesions (Rutherford stages 3, 4, 5 and 6)\n* Haemodynamically significant lesion\n* Written informed consent\n\nExclusion Criteria:\n\n* Restenosis\n* Non-atheromatous lesions (dysplasia, post-traumatic, inflammatory)\n* external iliac thrombosis and / or common femoral side to treat\n* Contraindication to open surgery or endovascular treatment\n* Contraindication to anesthesia\n* Indication of aorto-femoral, ilio-femoral, femoral-popliteal or femoro-tibialis bypass to associate with the common femoral revascularization\n* Indication of a surgical approach to the external iliac artery through a retroperitoneal\n* Asymptomatic lesions\n* Life expectancy less than one year\n* Refusing patient\n* Inability to monitor during the test period\n* Participation in another clinical trial\n* Pregnant Women\n* No written informed consent'}, 'identificationModule': {'nctId': 'NCT01353651', 'acronym': 'TECCO', 'briefTitle': 'Endovascular Versus Open Repair of the Common Femoral Artery', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Endovascular Versus Open Repair of the Common Femoral Artery: a Randomized Trial (TECCO)', 'orgStudyIdInfo': {'id': '10/6-Q'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endovascular treatment', 'interventionNames': ['Device: Endovascular treatment using self expandable nitinol STENTS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open repair treatment', 'interventionNames': ['Device: Open repair treatment']}], 'interventions': [{'name': 'Endovascular treatment using self expandable nitinol STENTS', 'type': 'DEVICE', 'description': 'A direct stenting will be performed.', 'armGroupLabels': ['Endovascular treatment']}, {'name': 'Open repair treatment', 'type': 'DEVICE', 'description': 'The surgeon will perform its usual technique to revascularize the common femoral artery', 'armGroupLabels': ['Open repair treatment']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amiens', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'city': 'Besançon', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'city': 'Bordeaux', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'city': 'Dijon', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'city': 'Lyon', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Marseille', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Nantes', 'country': 'France', 'facility': 'NCN Clinic', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nantes', 'country': 'France', 'facility': 'St Augustin Clinic', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nantes', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'city': 'Nice', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Paris', 'country': 'France', 'facility': 'University Hospital, HEGP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'country': 'France', 'facility': 'University Hospital, Henri Mondor', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Rouen', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'city': 'Saint-Etienne', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}, {'city': 'Strasbourg', 'country': 'France', 'facility': 'University Hospital', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'city': 'Villeurbanne', 'country': 'France', 'facility': 'Tonkin Clinic', 'geoPoint': {'lat': 45.76601, 'lon': 4.8795}}], 'overallOfficials': [{'name': 'Yann GOUEFFIC, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}