Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair (ACE)

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.

Study Overview

• Status: Completed
• Conditions: Elective Abdominal Aortic Aneurysm
• Intervention / Treatment: Procedure: Open repair; Procedure: 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.

• Study Type: Interventional
• Enrollment (Actual): 306
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Creteil, France, 94 010
    • Hopital Henri Mondor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Death and major adverse events	4 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Minor adverse events (systemic vascular or non vascular complications)	4 years

Collaborators and Investigators

• Sponsor: 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 - Hopital 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, Creteil; Study Chair: Marc Sapoval, MD, HEGP, Paris

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• controversies and updates in vascular surgery

Study record dates

Study Major Dates

• Study Start: January 1, 2003
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): February 1, 2009

Study Registration Dates

• First Submitted: September 16, 2005
• First Submitted That Met QC Criteria: September 19, 2005
• First Posted (Estimate): September 23, 2005

Study Record Updates

• Last Update Posted (Estimate): April 1, 2009
• Last Update Submitted That Met QC Criteria: March 31, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Keywords: Endovascular repair; AAA; Abdominal aortic aneurysm; Endograft; Open repair
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: P000708; AOM 98167