Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair

NCT00224718 | Completed DMC

• 2 other identifiers: P000708AOM 98167
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 1

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.

Conditions

Elective Abdominal Aortic Aneurysm

Keywords

Abdominal aortic aneurysm; Endograft; Open repair; Endovascular repair; AAA

Outcome Measures

Primary Outcomes (1)

• Death and major adverse events

  4 years

Secondary Outcomes (1)

• Minor adverse events (systemic vascular or non vascular complications)

  4 years

Study Arms (2)

1

ACTIVE COMPARATOR

surgery - open repair

Procedure: Open repair

2

EXPERIMENTAL

endovascular procedure

Procedure: Endovascular repair (with endograft)

Interventions

Endovascular repair (with endograft) PROCEDURE

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).

2

Open repair PROCEDURE

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.

1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Henri Mondor

Créteil, 94 010, France

Location

Related Publications (2)

• 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.

  PMID: 15944430 BACKGROUND

• 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.

  PMID: 21276681 DERIVED

Related Links

• controversies and updates in vascular surgery

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• Jean P Becquemin, MD

  Hopital Henri Mondor, Créteil

  STUDY CHAIR

• Marc Sapoval, MD

  HEGP, Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 23, 2005
• Study Start: January 1, 2003
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2009
• Last Updated: April 1, 2009

Record last verified: 2009-02

Locations

FR (1)