Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial

June 3, 2008 updated by: UMC Utrecht

Endovascular Versus Transabdominal Treatment of the Abdominal Aortic Aneurysm: the Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

392

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: OR
Open Aneurysm Repair
Procedure: Open Aneurysm Repair
Experimental: EVAR
Endovascular Aneurysm Repair
Procedure: Endovascular Aneurysm Repair
Other Names:
  • Excluder, Talent, Zenith, AneuRx

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
combined operative mortality and morbidity
Time Frame: 5-8 years
5-8 years

Secondary Outcome Measures

Outcome Measure
Time Frame
event free survival
Time Frame: 5-8 years
5-8 years
quality of life
Time Frame: 5-8 years
5-8 years
cost-effectiveness
Time Frame: 5-8 years
5-8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Investigators

  • Principal Investigator: J D Blankensteijn, MD, PhD, Radboud University Nijmegen Mecial Center, The Netherlands

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2000

Study Completion (Anticipated)

December 1, 2007

Study Registration Dates

First Submitted

January 10, 2007

First Submitted That Met QC Criteria

January 10, 2007

First Posted (Estimate)

January 11, 2007

Study Record Updates

Last Update Posted (Estimate)

June 4, 2008

Last Update Submitted That Met QC Criteria

June 3, 2008

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00/144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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