Clinical trial NCT00421330: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Keywords: Abdominal aortic aneurysm
AAA
randomised controlled trial
Endovascular repair
conventional open repair
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2007-01-11
Enrollment: 392
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: combined operative mortality and morbidity
timeFrame: 5-8 years
Secondary outcomes:
measure: event free survival
timeFrame: 5-8 years
measure: quality of life
timeFrame: 5-8 years
measure: cost-effectiveness
timeFrame: 5-8 years
Other outcomes:
Locations:
Study officials:
affiliation: Radboud University Nijmegen Mecial Center, The Netherlands
name: J D Blankensteijn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.