Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair (ACE)
This study has been completed.
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00224718
First received: September 16, 2005
Last updated: March 31, 2009
Last verified: February 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Elective Abdominal Aortic Aneurysm |
Procedure: Endovascular repair (with endograft) Procedure: Open repair |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | ACE Trial :Not Worn-Out Aneurism of the Abdominal Aorta Under Renal " Surgery Versus Endoprosthesis " |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- Death and major adverse events [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Minor adverse events (systemic vascular or non vascular complications) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
| Enrollment: | 306 |
| Study Start Date: | January 2003 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
surgery - open repair
|
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.
Other Name: Open repair
|
|
Experimental: 2
endovascular procedure
|
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).
Other Name: Endovascular repair (with endograft)
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients aged 50 years old or more (more than 80 possible depending on physiological age)
- Level 0, 1, or 2 of operative risk
- 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;
- Aortic neck superior or equal to 1.5 cm
- No stenosis superior or equal to 75% of the superior mesenteric artery
- Proximal neck angulation inferior to 80°
- Diameter of the iliac arteries compatible with introducer sheath
- Inform consent signed
Exclusion Criteria:
- Aneurysm involving the renal arteries or with the length of the neck less than 1.5 cm
- Thrombus or major calcification in the neck
- Diameter of the iliac arteries not compatible with introducer sheath
- Level 3 of operative risk
- History of major iodine allergy (Quincke oedema, anaphylactic shock)
- Other comorbidity with life expectancy less than 6 months
- Follow up impossible during the trial
- Participation in another trial
- Inform consent not signed
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00224718
Locations
| France | |
| Hopital Henri Mondor | |
| Creteil, France, 94 010 | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
| 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 |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Cecile Jourdain / Project manager, Departement Clinical Research of Developpement |
| ClinicalTrials.gov Identifier: | NCT00224718 History of Changes |
| Other Study ID Numbers: | P000708, AOM 98167 |
| Study First Received: | September 16, 2005 |
| Last Updated: | March 31, 2009 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Abdominal aortic aneurysm Endograft Open repair Endovascular repair AAA |
Additional relevant MeSH terms:
|
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013