Clinical trial NCT00224718: Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair
Official title: ACE Trial :Not Worn-Out Aneurism of the Abdominal Aorta Under Renal " Surgery Versus Endoprosthesis "
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elective Abdominal Aortic Aneurysm
Keywords: Abdominal aortic aneurysm
Endograft
Open repair
Endovascular repair
AAA
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2005-09-23
Enrollment: 306
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Death and major adverse events
timeFrame: 4 years
Secondary outcomes:
measure: Minor adverse events (systemic vascular or non vascular complications)
timeFrame: 4 years
Other outcomes:
Locations:
city: Creteil
country: France
facility: Hopital Henri Mondor
Study officials:
affiliation: CHU Angers - Hôtel Dieu
name: Yann JOUSSET, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital privé d'Antony
name: Jean M Pernes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique mutualiste des Eaux Claires, Grenoble
name: Pierre Y Meaulle, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Hôpital Nord, Saint-Etienne
name: Jean P Favre, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Charles Nicolle, Rouen
name: Jacques Watelet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHRU -Hôpital Trousseau, Tours
name: Patrick Lermusiaux, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Pontchaillou, Rennes
name: Jean F Heautot, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Cardiologique , Lille
name: Mohamad KOUSSA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital St Joseph, Marseille
name: Patrice BERGERON, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Nord Laennec, Nantes
name: Philippe CHAILLOU, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier René Dubos, Pontoise
name: Eric CHEYSSON, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CH de Valenciennes
name: Arnaud DEMON, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nouvelles Cliniques Nantaises, Nantes
name: Jean C PILLET, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU de Dijon - Hôpital du Bocage
name: Eric STEINMETZ, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique Pasteur Toulouse
name: Michel LEVADE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinique des Franciscaines, Nimes
name: Jean CARDON, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Timone, Marseille
name: Pierre-Edouard MAGNAN, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital St-Roch, Nice
name: Michel Batt, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital de la cavale blanche, Brest
name: Pierre GOUNY, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Pontchaillou
name: Antoine Lucas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hopital Henri Mondor, Créteil
name: Jean P Becquemin, MD
role: STUDY_CHAIR
affiliation: HEGP, Paris
name: Marc Sapoval, MD
role: STUDY_CHAIR
References:
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.
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.