Back to results

Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial

Primary Purpose

Abdominal Aortic Aneurysm

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Open Aneurysm Repair

Endovascular Aneurysm Repair

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm focused on measuring Abdominal aortic aneurysm, AAA, randomised controlled trial, Endovascular repair, conventional open repair

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

EVAR

Arm Description

Open Aneurysm Repair

Endovascular Aneurysm Repair

Outcomes

Primary Outcome Measures

combined operative mortality and morbidity

Secondary Outcome Measures

event free survival

quality of life

cost-effectiveness

Full Information

NCT ID

NCT00421330

First Posted

January 10, 2007

Last Updated

June 3, 2008

Sponsor

UMC Utrecht

1. Study Identification

Unique Protocol Identification Number

NCT00421330

Brief Title

Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2008

Overall Recruitment Status

Unknown status

Study Start Date

November 2000 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

UMC Utrecht

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abdominal Aortic Aneurysm

Keywords

Abdominal aortic aneurysm, AAA, randomised controlled trial, Endovascular repair, conventional open repair

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

392 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Open Aneurysm Repair

Arm Title

EVAR

Arm Type

Experimental

Arm Description

Endovascular Aneurysm Repair

Intervention Type

Procedure

Intervention Name(s)

Open Aneurysm Repair

Intervention Type

Procedure

Intervention Name(s)

Endovascular Aneurysm Repair

Other Intervention Name(s)

Excluder, Talent, Zenith, AneuRx

Primary Outcome Measure Information:

Title

combined operative mortality and morbidity

Time Frame

5-8 years

Secondary Outcome Measure Information:

Title

event free survival

Time Frame

5-8 years

Title

quality of life

Time Frame

5-8 years

Title

cost-effectiveness

Time Frame

5-8 years

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

J D Blankensteijn, MD, PhD

Organizational Affiliation

Radboud University Nijmegen Mecial Center, The Netherlands

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

12055570

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.

Results Reference

result

PubMed Identifier

15483279

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 abdominal aortic aneurysms. N Engl J Med. 2004 Oct 14;351(16):1607-18. doi: 10.1056/NEJMoa042002.

Results Reference

result

PubMed Identifier

14718892

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. doi: 10.1016/j.ejvs.2003.11.006.

Results Reference

result

PubMed Identifier

15615551

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. doi: 10.1583/04-1280R.1.

Results Reference

result

PubMed Identifier

15944424

Citation

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 abdominal aortic aneurysms. N Engl J Med. 2005 Jun 9;352(23):2398-405. doi: 10.1056/NEJMoa051255.

Results Reference

result

PubMed Identifier

29061270

Citation

van Schaik TG, Yeung KK, Verhagen HJ, de Bruin JL, van Sambeek MRHM, Balm R, Zeebregts CJ, van Herwaarden JA, Blankensteijn JD; DREAM trial participants. Long-term survival and secondary procedures after open or endovascular repair of abdominal aortic aneurysms. J Vasc Surg. 2017 Nov;66(5):1379-1389. doi: 10.1016/j.jvs.2017.05.122. Erratum In: J Vasc Surg. 2018 Feb;67(2):683.

Results Reference

derived

PubMed Identifier

24144736

Citation

de Bruin JL, Baas AF, Heymans MW, Buimer MG, Prinssen M, Grobbee DE, Blankensteijn JD; DREAM Study Group. Statin therapy is associated with improved survival after endovascular and open aneurysm repair. J Vasc Surg. 2014 Jan;59(1):39-44.e1. doi: 10.1016/j.jvs.2013.07.026. Epub 2013 Oct 18. Erratum In: J Vasc Surg. 2018 Feb;67(2):683.

Results Reference

derived

PubMed Identifier

24037566

Citation

de Bruin JL, Vervloet MG, Buimer MG, Baas AF, Prinssen M, Blankensteijn JD; DREAM Study Group. Renal function 5 years after open and endovascular aortic aneurysm repair from a randomized trial. Br J Surg. 2013 Oct;100(11):1465-70. doi: 10.1002/bjs.9280.

Results Reference

derived

PubMed Identifier

20484396

Citation

De Bruin JL, Baas AF, Buth J, Prinssen M, Verhoeven EL, Cuypers PW, van Sambeek MR, Balm R, Grobbee DE, Blankensteijn JD; DREAM Study Group. Long-term outcome of open or endovascular repair of abdominal aortic aneurysm. N Engl J Med. 2010 May 20;362(20):1881-9. doi: 10.1056/NEJMoa0909499.

Results Reference

derived

Learn more about this trial

Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial

We'll reach out to this number within 24 hrs