Angiotensin Converting Enzyme (ACE), Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair - Full Text View

Purpose

The aim of this trial is to compare two procedures used to treat patients with abdominal aortic aneurysm (AAA): open repair or endovascular repair.

Condition	Intervention
Elective Abdominal Aortic Aneurysm	Procedure: Endovascular repair (with endograft) Procedure: Open repair

MedlinePlus related topics:

Aneurysms

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	ACE Trial : Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair. Not Worn-Out Aneurism of the Abdominal Aorta Under Renal " Surgery Versus Endoprosthesis "

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Death and major adverse events [ Time Frame: 5 years ]

Secondary Outcome Measures:

Minor adverse events (systemic vascular or non vascular complications) [ Time Frame: 5 years ]

Estimated Enrollment:	300
Study Start Date:	January 2003
Estimated Study Completion Date:	November 2008

Arms	Assigned Interventions
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.
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).

Detailed Description:

This trial is to compare two procedures used to treat patients with abdominal aortic aneurysm: open repair or endovascular repair.

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
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

Contacts


Contact: Jean P Becquemin, MD	00 33 1 49 81 24 33	jean-pierre.becquemin@hmn.aphp.fr

Locations


France
	Hopital Henri Mondor	Recruiting
	Creteil, France, 94 010
	Contact: Jean P Becquemin, MD 00 33 149 81 24 33 jean-pierre.becquemin@hmn.aphp.fr
	Principal Investigator: Jean P Becquemin, MD

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

controversies and updates in vascular surgery This link exits the ClinicalTrials.gov site

Publications:

Lederle FA. Endovascular repair of abdominal aortic aneurysm--round two. N Engl J Med. 2005 Jun 9;352(23):2443-5. No abstract available.

Study ID Numbers:	P000708, AOM 98167
First Received:	September 16, 2005
Last Updated:	September 2, 2008
ClinicalTrials.gov Identifier:	NCT00224718
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Abdominal aortic aneurysm

ACE

Endograft

Open repair

Endovascular repair

AAA

Study placed in the following topic categories:

Aortic Diseases

Aneurysm

Aortic Aneurysm, Abdominal

Abdominal aortic aneurysm

Vascular Diseases

Aortic Aneurysm

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00224718