Abdominal Aortic Aneurysm
Conditions
Keywords
Abdominal aortic aneurysm, AAA, randomised controlled trial, Endovascular repair, conventional open repair
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.
Interventions
PROCEDUREOpen Aneurysm Repair
PROCEDUREEndovascular Aneurysm Repair
Sponsors
UMC Utrecht
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| combined operative mortality and morbidity | 5-8 years |
Secondary
| Measure | Time frame |
|---|---|
| event free survival | 5-8 years |
| quality of life | 5-8 years |
| cost-effectiveness | 5-8 years |
Outcome results
None listed