Status:
UNKNOWN
Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial
Lead Sponsor:
UMC Utrecht
Conditions:
Abdominal Aortic Aneurysm
Eligibility:
All Genders
Phase:
NA
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 adequ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
392 Patients enrolled
Trial Details
Trial ID
NCT00421330
Start Date
November 1 2000
End Date
December 1 2007
Last Update
June 4 2008
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