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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014