NCT00421330

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
392

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2000

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

June 4, 2008

Status Verified

June 1, 2008

First QC Date

January 10, 2007

Last Update Submit

June 3, 2008

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal aortic aneurysmAAArandomised controlled trialEndovascular repairconventional open repair

Outcome Measures

Primary Outcomes (1)

  • combined operative mortality and morbidity

    5-8 years

Secondary Outcomes (3)

  • event free survival

    5-8 years

  • quality of life

    5-8 years

  • cost-effectiveness

    5-8 years

Study Arms (2)

OR

ACTIVE COMPARATOR

Open Aneurysm Repair

Procedure: Open Aneurysm Repair

EVAR

EXPERIMENTAL

Endovascular Aneurysm Repair

Procedure: Endovascular Aneurysm Repair

Interventions

Open Aneurysm RepairPROCEDURE
OR
Endovascular Aneurysm RepairPROCEDURE
Also known as: Excluder, Talent, Zenith, AneuRx
EVAR

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (9)

  • 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.

    PMID: 12055570RESULT

  • 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.

    PMID: 15483279RESULT

  • 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.

    PMID: 14718892RESULT

  • 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.

    PMID: 15615551RESULT

  • 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.

    PMID: 15944424RESULT

  • 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.

    PMID: 29061270DERIVED

  • 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.

    PMID: 24144736DERIVED

  • 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.

    PMID: 24037566DERIVED

  • 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.

    PMID: 20484396DERIVED

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeBlood Vessel Prosthesis ImplantationVascular GraftingMinimally Invasive Surgical ProceduresProsthesis Implantation

Study Officials

  • J D Blankensteijn, MD, PhD

    Radboud University Nijmegen Mecial Center, The Netherlands

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 10, 2007

First Posted

January 11, 2007

Study Start

November 1, 2000

Study Completion

December 1, 2007

Last Updated

June 4, 2008

Record last verified: 2008-06