Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial

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Disease Information

Descriptive Information
Brief Title † Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial
Official Title † Endovascular Versus Transabdominal Treatment of the Abdominal Aortic Aneurysm: the Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial
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.
Study Phase N/A
Study Type † Interventional
Study Design † Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Outcome Measure † combined operative mortality and morbidity
Secondary Outcome Measure † event free survival
Condition † Abdominal Aortic Aneurysm
Intervention † ProcedureOpen Aneurysm Repair
Study Arms / Comparison Groups OR Open Aneurysm Repair EVAR Endovascular Aneurysm Repair
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Procedure
Estimated Enrollment † 392
Start Date † November 2000
Completion Date December 2007
Primary Completion Date
Eligibility Criteria † 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
Gender Both
Ages N/A - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries †
Administrative Information
NCT ID † NCT00421330
Organization ID 00/144
Secondary IDs ††
Responsible Party
Study Sponsor † UMC Utrecht
Collaborators ††
Investigators † Principal Investigator: J D Blankensteijn, MD, PhD, Radboud University Nijmegen Mecial Center, The Netherlands
Information Provided By
Verification Date June 2008
First Received Date † January 10, 2007
Last Updated Date June 3, 2008
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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