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| ID | Type | Description | Link |
|---|---|---|---|
| AOM 98167 |
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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.
The 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.
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.
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | surgery - open repair |
|
| 2 | Experimental | endovascular procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endovascular repair (with endograft) | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Death and major adverse events | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Minor adverse events (systemic vascular or non vascular complications) | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Henri Mondor | Créteil | 94 010 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15944430 | Background | 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. | |
| 21276681 | Derived | 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. |
| Label | URL |
|---|---|
| controversies and updates in vascular surgery | View source |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Open repair | Procedure | 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. |
|
| 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 | Principal Investigator |
| Jean P Becquemin, MD | Hopital Henri Mondor, Créteil | Study Chair |
| Marc Sapoval, MD | HEGP, Paris | Study Chair |
| D001018 |
| Aortic Diseases |