Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT00224718
Status:
COMPLETED
Last Update Posted:
2009-04-01
First Post:
2005-09-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017544', 'term': 'Aortic Aneurysm, Abdominal'}], 'ancestors': [{'id': 'D001014', 'term': 'Aortic Aneurysm'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001018', 'term': 'Aortic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 306}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-31', 'studyFirstSubmitDate': '2005-09-16', 'studyFirstSubmitQcDate': '2005-09-19', 'lastUpdatePostDateStruct': {'date': '2009-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death and major adverse events', 'timeFrame': '4 years'}], 'secondaryOutcomes': [{'measure': 'Minor adverse events (systemic vascular or non vascular complications)', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Abdominal aortic aneurysm', 'Endograft', 'Open repair', 'Endovascular repair', 'AAA'], 'conditions': ['Elective Abdominal Aortic Aneurysm']}, 'referencesModule': {'references': [{'pmid': '15944430', 'type': 'BACKGROUND', 'citation': 'Lederle FA. Endovascular repair of abdominal aortic aneurysm--round two. N Engl J Med. 2005 Jun 9;352(23):2443-5. doi: 10.1056/NEJMe058126. No abstract available.'}, {'pmid': '21276681', 'type': 'DERIVED', 'citation': 'Becquemin JP, Pillet JC, Lescalie F, Sapoval M, Goueffic Y, Lermusiaux P, Steinmetz E, Marzelle J; ACE trialists. A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients. J Vasc Surg. 2011 May;53(5):1167-1173.e1. doi: 10.1016/j.jvs.2010.10.124. Epub 2011 Jan 26.'}], 'seeAlsoLinks': [{'url': 'http://www.cacvs.org', 'label': 'controversies and updates in vascular surgery'}]}, 'descriptionModule': {'briefSummary': 'Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5 cm in diameter.\n\nThe aim of the study is to compare the mortality and the occurrence of severe general, vascular and local complications in two groups of patients treated by either by open surgery or by EVAR (EndoVascular Aneurysm Repair). The main outcome criteria and the secondary endpoint are respectively the survival without severe complications and minor morbidity.', 'detailedDescription': 'ACE Trial :Not Worn-Out Aneurism of the Abdominal Aorta Under Renal " Surgery Versus Endoprosthesis Abdominal aortic aneurysm (AAA) is a life threatening disease. There is a consensus to propose surgical repair in patients with a reasonable operative risk when the AAA exceeds 5 cm in diameter.\n\nThe aim of the study is to compare the mortality and the occurrence of severe general, vascular and local complications in two groups of patients treated by either by open surgery or by EVAR (EndoVascular Aneurysm Repair). The main outcome criteria and the secondary endpoint are respectively the survival without severe complications and minor morbidity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 50 years old or more (more than 80 possible depending on physiological age)\n* Level 0, 1, or 2 of operative risk\n* Abdominal aortic aneurysm with a diameter \\> or equal to 50 mm or \\> or equal to 40 mm if rapid growing (10 mm or more in a year), or painful, or saccular aneurysms, or aneurisms of common iliac arteries with a diameter equal or superior to 30 mm; or women with a diameter equal to 45 mm;\n* Aortic neck superior or equal to 1.5 cm\n* No stenosis superior or equal to 75% of the superior mesenteric artery\n* Proximal neck angulation inferior to 80°\n* Diameter of the iliac arteries compatible with introducer sheath\n* Inform consent signed\n\nExclusion Criteria:\n\n* Aneurysm involving the renal arteries or with the length of the neck less than 1.5 cm\n* Thrombus or major calcification in the neck\n* Diameter of the iliac arteries not compatible with introducer sheath\n* Level 3 of operative risk\n* History of major iodine allergy (Quincke oedema, anaphylactic shock)\n* Other comorbidity with life expectancy less than 6 months\n* Follow up impossible during the trial\n* Participation in another trial\n* Inform consent not signed'}, 'identificationModule': {'nctId': 'NCT00224718', 'acronym': 'ACE', 'briefTitle': 'Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'ACE Trial :Not Worn-Out Aneurism of the Abdominal Aorta Under Renal " Surgery Versus Endoprosthesis "', 'orgStudyIdInfo': {'id': 'P000708'}, 'secondaryIdInfos': [{'id': 'AOM 98167'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'surgery - open repair', 'interventionNames': ['Procedure: Open repair']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'endovascular procedure', 'interventionNames': ['Procedure: Endovascular repair (with endograft)']}], 'interventions': [{'name': 'Endovascular repair (with endograft)', 'type': 'PROCEDURE', 'description': 'An endovascular stent graft is a tube composed of fabric supported by a metal mesh called a stent. It can be used for a variety of conditions involving the blood vessels, but most commonly to reinforce a weak spot in an artery called an aneurysm. Over time, blood pressure and other factors can cause this weak area to bulge like a balloon and eventually enlarge and rupture. The stent graft seals tightly with your artery above and below the aneurysm. The graft is stronger than the weakened artery and allows blood to pass through it without pushing on the bulge. Physicians typically use endovascular stent grafting to treat abdominal aortic aneurysms (AAAs).', 'armGroupLabels': ['2']}, {'name': 'Open repair', 'type': 'PROCEDURE', 'description': 'Conventional repair consist in open repair. Different types of surgery can be done : minimal incision aortic surgery (MIAS), transperitoneal approach (TPA), retroperitoneal repair, or conventional median laparotomy.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94 010', 'city': 'Créteil', 'country': 'France', 'facility': 'Hopital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'overallOfficials': [{'name': 'Yann JOUSSET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Angers - Hôtel Dieu'}, {'name': 'Jean M Pernes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Hôpital privé d'Antony"}, {'name': 'Pierre Y Meaulle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique mutualiste des Eaux Claires, Grenoble'}, {'name': 'Jean P Favre, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Hôpital Nord, Saint-Etienne'}, {'name': 'Jacques Watelet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Charles Nicolle, Rouen'}, {'name': 'Patrick Lermusiaux, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU -Hôpital Trousseau, Tours'}, {'name': 'Jean F Heautot, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Pontchaillou, Rennes'}, {'name': 'Mohamad KOUSSA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Cardiologique , Lille'}, {'name': 'Patrice BERGERON, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital St Joseph, Marseille'}, {'name': 'Philippe CHAILLOU, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital Nord Laennec, Nantes'}, {'name': 'Eric CHEYSSON, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier René Dubos, Pontoise'}, {'name': 'Arnaud DEMON, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CH de Valenciennes'}, {'name': 'Jean C PILLET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nouvelles Cliniques Nantaises, Nantes'}, {'name': 'Eric STEINMETZ, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Dijon - Hôpital du Bocage'}, {'name': 'Michel LEVADE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Pasteur Toulouse'}, {'name': 'Jean CARDON, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique des Franciscaines, Nimes'}, {'name': 'Pierre-Edouard MAGNAN, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Timone, Marseille'}, {'name': 'Michel Batt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hôpital St-Roch, Nice'}, {'name': 'Pierre GOUNY, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hopital de la cavale blanche, Brest'}, {'name': 'Antoine Lucas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU Pontchaillou'}, {'name': 'Jean P Becquemin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Hopital Henri Mondor, Créteil'}, {'name': 'Marc Sapoval, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'HEGP, Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Cecile Jourdain / Project manager', 'oldOrganization': 'Departement Clinical Research of Developpement'}}}}