Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial

Not Applicable

• Conditions: Abdominal Aortic Aneurysm
• Interventions: Procedure: Open Aneurysm Repair; Procedure: Endovascular Aneurysm Repair

• Registration Number: NCT00421330
• Lead Sponsor: UMC Utrecht

Brief Summary

The purpose of this trial is to assess whether the new endovascular repair technique of the abdominal aortic aneurysm (AAA) is an adequate substitute of the conventional AAA repair.

Detailed Description

After the introduction of endovascular repair of abdominal aortic aneurysms (AAA), both benefits and drawbacks of this new technique have been reported. To assess whether the new technique is an adequate substitute of conventional AAA repair, a randomised study is required. The DREAM trial is a randomised multicenter trial enrolling patients eligible for elective treatment of infrarenal AAAs. The primary endpoint is combined operative mortality and morbidity. Secondary endpoints and additional assessments include event-free survival, quality of life,and costs.

Study Timeline

• Study Start: 2000-11
• Study First Submitted: 2007-01-10
• Study First Submitted QC: 2007-01-10
• Study First Posted: 2007-01-11
• Study Completion: 2007-12
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-03
• Last Update Posted: 2008-06-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 392

Inclusion Criteria

• Asymptomatic, infrarenal AAA that requires surgery
• Adequate infrarenal neck
• Other aortic-iliac anatomical configuration suitable for EVAR according to the criteria of the device to be used
• Patient having a life expectation of at least 2 years and cleared for transabdominal intervention
• Signed informed consent

Exclusion Criteria

• ruptured AAA or symptomatic AAA, which requires emergency surgery
• maximum aneurysm diameter< 5.0 cm
• suprarenal AAA
• Inflammatory AAA (more than minimal wall thickening)
• infrarenal neck unsuitable for endovascular fixation or aortic-iliac anatomic configuration otherwise unsuitable for EVAR according to criteria of the device to be used
• bilateral retroperitoneal incision required for EVAR
• sacrifice of both hypogastric arteries required
• anatomical variations, i.e. horseshoe-kidney, arteries requiring reimplantation
• patient unsuitable for laparotomy
• administration of contrast agent not possible: proved, severe systemic reaction to contrast agent
• active infection present
• transplantation-patients
• limited life expectation due to other illness (< 2 year)
• non-iatrogenic bleeding diathesis
• connective tissue disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OR	Open Aneurysm Repair	Open Aneurysm Repair
EVAR	Endovascular Aneurysm Repair	Endovascular Aneurysm Repair

Primary Outcome Measures

Name	Time	Method
combined operative mortality and morbidity	5-8 years

Secondary Outcome Measures

Name	Time	Method
event free survival	5-8 years
quality of life	5-8 years
cost-effectiveness	5-8 years