Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair

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

Interventions

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).

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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Yann JOUSSET, MD · CHU Angers - Hôtel Dieu

• Jean M Pernes, MD · Hôpital privé d'Antony

• Pierre Y Meaulle, MD · Clinique mutualiste des Eaux Claires, Grenoble

• Jean P Favre, MD · CHU Hôpital Nord, Saint-Etienne

• Jacques Watelet, MD · Hôpital Charles Nicolle, Rouen

• Patrick Lermusiaux, MD · CHRU -Hôpital Trousseau, Tours

• Jean F Heautot, MD · CHU de Pontchaillou, Rennes

• Mohamad KOUSSA, MD · Hôpital Cardiologique , Lille

• Patrice BERGERON, MD · Hôpital St Joseph, Marseille

• Philippe CHAILLOU, MD · Hôpital Nord Laennec, Nantes

• Eric CHEYSSON, MD · Centre Hospitalier René Dubos, Pontoise

• Arnaud DEMON, MD · CH de Valenciennes

• Jean C PILLET, MD · Nouvelles Cliniques Nantaises, Nantes

• Eric STEINMETZ, MD · CHU de Dijon - Hôpital du Bocage

• Michel LEVADE, MD · Clinique Pasteur Toulouse

• Jean CARDON, MD · Clinique des Franciscaines, Nimes

• Pierre-Edouard MAGNAN, MD · CHU Timone, Marseille

• Michel Batt, MD · Hôpital St-Roch, Nice

• Pierre GOUNY, MD · Hopital de la cavale blanche, Brest

• Antoine Lucas, MD · CHU Pontchaillou

• Jean P Becquemin, MD · Hopital Henri Mondor, Créteil

• Marc Sapoval, MD · HEGP, Paris

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2003-01-31

Primary Completion

2008-02-29

Completion

2009-02-28

Countries

• France

Study Locations