Elective Abdominal Aortic Aneurism – Open Versus Endovascular Repair

Brief Title

Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair

Official Title

ACE Trial :Not Worn-Out Aneurism of the Abdominal Aorta Under Renal " Surgery Versus Endoprosthesis "

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.
    

Study Type

Interventional

Primary Outcome

Death and major adverse events

Secondary Outcome

 Minor adverse events (systemic vascular or non vascular complications)

Condition

Elective Abdominal Aortic Aneurysm

Intervention

Endovascular repair (with endograft)

Study Arms / Comparison Groups

 1

Description:  surgery - open repair

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Procedure

Estimated Enrollment

306

Start Date

January 2003

Completion Date

February 2009

Primary Completion Date

February 2008

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
      

Gender

All

Ages

50 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Yann JOUSSET, MD, , 

Location Countries

France

Location Countries

France

NCT ID

NCT00224718

Organization ID

P000708

Secondary IDs

AOM 98167

Study Sponsor

Assistance Publique - Hôpitaux de Paris

Study Sponsor

Yann JOUSSET, MD, Principal Investigator, CHU Angers - Hôtel Dieu

Verification Date

February 2009