Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial

UMC Utrecht392 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

392

Conditions

Abdominal Aortic Aneurysm

Interventions

Open Aneurysm RepairPROCEDURE

Endovascular Aneurysm RepairPROCEDURE

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

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

cost-effectiveness

Time frame: 5-8 years

Data from ClinicalTrials.gov

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