Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial

UMC Utrecht

Status: Unknown

Conditions: Abdominal Aortic Aneurysm

Treatments: Procedure: Open Aneurysm Repair; Procedure: Endovascular Aneurysm Repair

Study type: Interventional

Funder types: Other

Identifiers

NCT00421330

00/144

Details and patient eligibility

About

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.

Full 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.

Enrollment: 392 patients

Sex: All

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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392 participants in 2 patient groups

OR

Active Comparator group

Description:

Open Aneurysm Repair

Treatment:

Procedure: Open Aneurysm Repair

EVAR

Experimental group

Description:

Endovascular Aneurysm Repair

Treatment:

Procedure: Endovascular Aneurysm Repair