Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial

Sponsor

UMC Utrecht (Other)

Overall Status

Unknown status

CT.gov ID

NCT00421330

Collaborator

(none)

392

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm	Procedure: Open Aneurysm Repair Procedure: Endovascular Aneurysm Repair	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

392 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Endovascular Versus Transabdominal Treatment of the Abdominal Aortic Aneurysm: the Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial

Study Start Date :

Nov 1, 2000

Anticipated Study Completion Date :

Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: OR Open Aneurysm Repair	Procedure: Open Aneurysm Repair
Experimental: EVAR Endovascular Aneurysm Repair	Procedure: Endovascular Aneurysm Repair Other Names: Excluder, Talent, Zenith, AneuRx

Arm

Intervention/Treatment

Active Comparator: OR

Open Aneurysm Repair

Procedure: Open Aneurysm Repair

Experimental: EVAR

Endovascular Aneurysm Repair

Procedure: Endovascular Aneurysm Repair

Other Names:

Excluder, Talent, Zenith, AneuRx

Outcome Measures

Primary Outcome Measures

combined operative mortality and morbidity [5-8 years]

Secondary Outcome Measures

event free survival [5-8 years]
quality of life [5-8 years]
cost-effectiveness [5-8 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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