Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial
NCT ID: NCT00421330
Last Updated: 2008-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
392 participants
INTERVENTIONAL
2000-11-30
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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OR
Open Aneurysm Repair
Open Aneurysm Repair
EVAR
Endovascular Aneurysm Repair
Endovascular Aneurysm Repair
Interventions
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Open Aneurysm Repair
Endovascular Aneurysm Repair
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
ALL
No
Sponsors
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UMC Utrecht
OTHER
Principal Investigators
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J D Blankensteijn, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Nijmegen Mecial Center, The Netherlands
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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00/144
Identifier Type: -
Identifier Source: org_study_id