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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00224718 |
The aim of this trial is to compare two procedures used to treat patients with abdominal aortic aneurysm (AAA): open repair or endovascular repair.
Condition | Intervention |
Elective Abdominal Aortic Aneurysm |
Procedure: Endovascular repair (with endograft) Procedure: Open repair |
MedlinePlus related topics: | Aneurysms |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | ACE Trial : Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair. Not Worn-Out Aneurism of the Abdominal Aorta Under Renal " Surgery Versus Endoprosthesis " |
Estimated Enrollment: | 300 |
Study Start Date: | January 2003 |
Estimated Study Completion Date: | November 2008 |
Arms | Assigned Interventions |
1
surgery - open repair
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Procedure: Open repair
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.
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2
endovascular procedure
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Procedure: Endovascular repair (with endograft)
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).
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This trial is to compare two procedures used to treat patients with abdominal aortic aneurysm: open repair or endovascular repair.
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jean P Becquemin, MD | 00 33 1 49 81 24 33 | jean-pierre.becquemin@hmn.aphp.fr |
France | |||||
Hopital Henri Mondor | Recruiting | ||||
Creteil, France, 94 010 | |||||
Contact: Jean P Becquemin, MD 00 33 149 81 24 33 jean-pierre.becquemin@hmn.aphp.fr | |||||
Principal Investigator: Jean P Becquemin, MD |
Assistance Publique - Hôpitaux de Paris |
Principal Investigator: | Yann JOUSSET, MD | CHU Angers - Hôtel Dieu |
Principal Investigator: | Jean M Pernes, MD | Hôpital privé d'Antony |
Principal Investigator: | Pierre Y Meaulle, MD | Clinique mutualiste des Eaux Claires, Grenoble |
Principal Investigator: | Jean P Favre, MD | CHU Hôpital Nord, Saint-Etienne |
Principal Investigator: | Jacques Watelet, MD | Hôpital Charles Nicolle, Rouen |
Principal Investigator: | Patrick Lermusiaux, MD | CHRU -Hôpital Trousseau, Tours |
Principal Investigator: | Jean F Heautot, MD | CHU de Pontchaillou, Rennes |
Principal Investigator: | Mohamad KOUSSA, MD | Hôpital Cardiologique , Lille |
Principal Investigator: | Patrice BERGERON, MD | Hôpital St Joseph, Marseille |
Principal Investigator: | Philippe CHAILLOU, MD | Hôpital Nord Laennec, Nantes |
Principal Investigator: | Eric CHEYSSON, MD | Centre Hospitalier René Dubos, Pontoise |
Principal Investigator: | Arnaud DEMON, MD | CH de Valenciennes |
Principal Investigator: | Jean C PILLET, MD | Nouvelles cliniques nantaises, Nantes |
Principal Investigator: | Eric STEINMETZ, MD | CHU de Dijon - Hôpital du Bocage |
Principal Investigator: | Michel LEVADE, MD | Clinique Pasteur, Toulouse |
Principal Investigator: | Jean CARDON, MD | Clinique des Franciscaines, Nimes |
Principal Investigator: | Pierre-Edouard MAGNAN, MD | CHU Timone, Marseille |
Principal Investigator: | Michel Batt, MD | Hôpital St-Roch, Nice |
Principal Investigator: | Pierre GOUNY, MD | Hopital de la cavale blanche, Brest |
Principal Investigator: | Antoine Lucas, MD | CHU Pontchaillou |
Study Chair: | Jean P Becquemin, MD | Hopital Henri Mondor, Créteil |
Study Chair: | Marc Sapoval, MD | HEGP, Paris |
controversies and updates in vascular surgery 
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Study ID Numbers: | P000708, AOM 98167 |
First Received: | September 16, 2005 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00224718 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
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