Elective Abdominal Aortic Aneurism - Open Versus Endovascular Repair

Elective Abdominal Aortic Aneurysm Clinical Trial

— ACE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00224718
• Other study ID #: P000708
• Secondary ID: AOM 98167
• Status: Completed
• Phase: N/A
• First received: September 16, 2005
• Last updated: March 31, 2009
• Start date: January 2003
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: February 2009
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Elective Abdominal Aortic Aneurysm

Intervention

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).
• 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.

Locations

Country	Name	City	State
France	Hopital Henri Mondor	Creteil

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Lederle FA. Endovascular repair of abdominal aortic aneurysm--round two. N Engl J Med. 2005 Jun 9;352(23):2443-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Death and major adverse events		4 years	Yes
Secondary	Minor adverse events (systemic vascular or non vascular complications)		4 years	Yes

External Links

•   controversies and updates in vascular surgery