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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00421330
Other study ID # 00/144
Secondary ID
Status Active, not recruiting
Phase N/A
First received January 10, 2007
Last updated June 3, 2008
Start date November 2000
Est. completion date December 2007

Study information

Verified date June 2008
Source UMC Utrecht
Contact n/a
Is FDA regulated No
Health authority Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 392
Est. completion date December 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Open Aneurysm Repair

Endovascular Aneurysm Repair


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
UMC Utrecht

References & Publications (5)

Blankensteijn JD, de Jong SE, Prinssen M, van der Ham AC, Buth J, van Sterkenburg SM, Verhagen HJ, Buskens E, Grobbee DE; Dutch Randomized Endovascular Aneurysm Management (DREAM) Trial Group. Two-year outcomes after conventional or endovascular repair of — View Citation

Prinssen M, Buskens E, Blankensteijn JD. The Dutch Randomised Endovascular Aneurysm Management (DREAM) trial. Background, design and methods. J Cardiovasc Surg (Torino). 2002 Jun;43(3):379-84. — View Citation

Prinssen M, Buskens E, Blankensteijn JD; DREAM trial participants. Quality of life endovascular and open AAA repair. Results of a randomised trial. Eur J Vasc Endovasc Surg. 2004 Feb;27(2):121-7. — View Citation

Prinssen M, Buskens E, Nolthenius RP, van Sterkenburg SM, Teijink JA, Blankensteijn JD. Sexual dysfunction after conventional and endovascular AAA repair: results of the DREAM trial. J Endovasc Ther. 2004 Dec;11(6):613-20. — View Citation

Prinssen M, Verhoeven EL, Buth J, Cuypers PW, van Sambeek MR, Balm R, Buskens E, Grobbee DE, Blankensteijn JD; Dutch Randomized Endovascular Aneurysm Management (DREAM)Trial Group. A randomized trial comparing conventional and endovascular repair of abdom — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary combined operative mortality and morbidity 5-8 years
Secondary event free survival 5-8 years
Secondary quality of life 5-8 years
Secondary cost-effectiveness 5-8 years
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