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

Primary Purpose

Elective Abdominal Aortic Aneurysm

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Endovascular repair (with endograft)
Open repair
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Elective Abdominal Aortic Aneurysm focused on measuring Abdominal aortic aneurysm, Endograft, Open repair, Endovascular repair, AAA

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Henri Mondor

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

surgery - open repair

endovascular procedure

Outcomes

Primary Outcome Measures

Death and major adverse events

Secondary Outcome Measures

Minor adverse events (systemic vascular or non vascular complications)

Full Information

First Posted
September 16, 2005
Last Updated
March 31, 2009
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT00224718
Brief Title
Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair
Acronym
ACE
Official Title
ACE Trial :Not Worn-Out Aneurism of the Abdominal Aorta Under Renal " Surgery Versus Endoprosthesis "
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Elective Abdominal Aortic Aneurysm
Keywords
Abdominal aortic aneurysm, Endograft, Open repair, Endovascular repair, AAA

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
surgery - open repair
Arm Title
2
Arm Type
Experimental
Arm Description
endovascular procedure
Intervention Type
Procedure
Intervention Name(s)
Endovascular repair (with endograft)
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Open repair
Intervention Description
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.
Primary Outcome Measure Information:
Title
Death and major adverse events
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Minor adverse events (systemic vascular or non vascular complications)
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yann JOUSSET, MD
Organizational Affiliation
CHU Angers - Hôtel Dieu
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean M Pernes, MD
Organizational Affiliation
Hôpital privé d'Antony
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre Y Meaulle, MD
Organizational Affiliation
Clinique mutualiste des Eaux Claires, Grenoble
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean P Favre, MD
Organizational Affiliation
CHU Hôpital Nord, Saint-Etienne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacques Watelet, MD
Organizational Affiliation
Hôpital Charles Nicolle, Rouen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrick Lermusiaux, MD
Organizational Affiliation
CHRU -Hôpital Trousseau, Tours
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean F Heautot, MD
Organizational Affiliation
CHU de Pontchaillou, Rennes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamad KOUSSA, MD
Organizational Affiliation
Hôpital Cardiologique , Lille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Patrice BERGERON, MD
Organizational Affiliation
Hôpital St Joseph, Marseille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philippe CHAILLOU, MD
Organizational Affiliation
Hôpital Nord Laennec, Nantes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric CHEYSSON, MD
Organizational Affiliation
Centre Hospitalier René Dubos, Pontoise
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arnaud DEMON, MD
Organizational Affiliation
CH de Valenciennes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean C PILLET, MD
Organizational Affiliation
Nouvelles Cliniques Nantaises, Nantes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eric STEINMETZ, MD
Organizational Affiliation
CHU de Dijon - Hôpital du Bocage
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michel LEVADE, MD
Organizational Affiliation
Clinique Pasteur Toulouse
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean CARDON, MD
Organizational Affiliation
Clinique des Franciscaines, Nimes
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre-Edouard MAGNAN, MD
Organizational Affiliation
CHU Timone, Marseille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michel Batt, MD
Organizational Affiliation
Hôpital St-Roch, Nice
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pierre GOUNY, MD
Organizational Affiliation
Hopital de la cavale blanche, Brest
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antoine Lucas, MD
Organizational Affiliation
CHU Pontchaillou
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean P Becquemin, MD
Organizational Affiliation
Hopital Henri Mondor, Créteil
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Marc Sapoval, MD
Organizational Affiliation
HEGP, Paris
Official's Role
Study Chair
Facility Information:
Facility Name
Hopital Henri Mondor
City
Creteil
ZIP/Postal Code
94 010
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
15944430
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.
Results Reference
background
PubMed Identifier
21276681
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.
Results Reference
derived
Links:
URL
http://www.cacvs.org
Description
controversies and updates in vascular surgery

Learn more about this trial

Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair

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