Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial

Abdominal Aortic Aneurysm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00421330
• Other study ID #: 00/144
• 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
• 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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

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