Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by UMC Utrecht.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00421330
First received: January 10, 2007
Last updated: June 3, 2008
Last verified: June 2008
  Purpose

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 Intervention
Abdominal Aortic Aneurysm
Procedure: Open Aneurysm Repair
Procedure: Endovascular Aneurysm Repair

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endovascular Versus Transabdominal Treatment of the Abdominal Aortic Aneurysm: the Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

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

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

Enrollment: 392
Study Start Date: November 2000
Estimated Study Completion Date: December 2007
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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< 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00421330

Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: J D Blankensteijn, MD, PhD Radboud University Nijmegen Mecial Center, The Netherlands
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00421330     History of Changes
Other Study ID Numbers: 00/144
Study First Received: January 10, 2007
Last Updated: June 3, 2008
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
Abdominal aortic aneurysm
AAA
randomised controlled trial
Endovascular repair
conventional open repair

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on July 29, 2014