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Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00421330
Recruitment Status : Unknown
Verified June 2008 by UMC Utrecht.
Recruitment status was:  Active, not recruiting
First Posted : January 11, 2007
Last Update Posted : June 4, 2008
Information provided by:
UMC Utrecht

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.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Procedure: Open Aneurysm Repair Procedure: Endovascular Aneurysm Repair Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 392 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endovascular Versus Transabdominal Treatment of the Abdominal Aortic Aneurysm: the Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial
Study Start Date : November 2000
Estimated Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: OR
Open Aneurysm Repair
Procedure: Open Aneurysm Repair
Experimental: EVAR
Endovascular Aneurysm Repair
Procedure: Endovascular Aneurysm Repair
Other Name: Excluder, Talent, Zenith, AneuRx

Primary Outcome Measures :
  1. combined operative mortality and morbidity [ Time Frame: 5-8 years ]

Secondary Outcome Measures :
  1. event free survival [ Time Frame: 5-8 years ]
  2. quality of life [ Time Frame: 5-8 years ]
  3. cost-effectiveness [ Time Frame: 5-8 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00421330

Sponsors and Collaborators
UMC Utrecht
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Principal Investigator: J D Blankensteijn, MD, PhD Radboud University Nijmegen Mecial Center, The Netherlands
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00421330    
Other Study ID Numbers: 00/144
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: June 4, 2008
Last Verified: June 2008
Keywords provided by UMC Utrecht:
Abdominal aortic aneurysm
randomised controlled trial
Endovascular repair
conventional open repair
Additional relevant MeSH terms:
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Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases