Abdominal Aortic Aneurysm Clinical Trial
Official title:
Endovascular Versus Transabdominal Treatment of the Abdominal Aortic Aneurysm: the Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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UMC Utrecht |
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
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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