This trial is active, not recruiting.

Condition abdominal aortic aneurysm
Treatments open aneurysm repair, endovascular aneurysm repair
Sponsor UMC Utrecht
Start date November 2000
End date December 2007
Trial size 392 participants
Trial identifier NCT00421330, 00/144


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Open Aneurysm Repair
open aneurysm repair
Endovascular Aneurysm Repair
endovascular aneurysm repair Excluder, Talent, Zenith, AneuRx

Primary Outcomes

combined operative mortality and morbidity
time frame: 5-8 years

Secondary Outcomes

event free survival
time frame: 5-8 years
quality of life
time frame: 5-8 years
time frame: 5-8 years

Eligibility Criteria

Male or female participants of any age.

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

Additional Information

Official title Endovascular Versus Transabdominal Treatment of the Abdominal Aortic Aneurysm: the Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial
Principal investigator J D Blankensteijn, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2008.
Information provided to ClinicalTrials.gov by UMC Utrecht.