Abdominal Aortic AneurysmNCT00421330
Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial
A study testing Open Aneurysm Repair and Endovascular Aneurysm Repair in people with Abdominal Aortic Aneurysm, run by UMC Utrecht.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- Open Aneurysm Repair and Endovascular Aneurysm Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- No sites listed yet
- Study dates
- Nov 2000to Dec 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
About this study
Official title: Endovascular Versus Transabdominal Treatment of the Abdominal Aortic Aneurysm: the Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial
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.
Read the 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.
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- Open Aneurysm Repair, Endovascular Aneurysm Repair
- Keywords
- Abdominal aortic aneurysm, AAA, randomised controlled trial, Endovascular repair, conventional open repair
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Aneurysm RepairProcedure or surgery
Endovascular Aneurysm RepairProcedure or surgery
Also called Excluder, Talent, Zenith, AneuRx
| Study group | Role | What they receive |
|---|---|---|
| OR | Active comparator | Open Aneurysm Repair Receives: Procedure: Open Aneurysm Repair |
| EVAR | Experimental | Endovascular Aneurysm Repair Receives: Procedure: Endovascular Aneurysm Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
combined operative mortality and morbidity
Measured: 5-8 years
Secondary outcomes (3)
event free survival
Measured: 5-8 years
quality of life
Measured: 5-8 years
cost-effectiveness
Measured: 5-8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2007 (estimated)
- Study startNov 2000
- Study completionDec 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Investigators
- J D Blankensteijn, MD, PhD, Principal investigator, Radboud University Nijmegen Mecial Center, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00421330
- Sponsor's protocol ID
- 00/144
- Status last verified
- Jun 2008
- First submitted
- 10 Jan 2007
- Last updated
- 4 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 12055570Prinssen 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.
PubMed 15483279Prinssen 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.
PubMed 14718892Prinssen 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.
PubMed 15615551Blankensteijn 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.
PubMed 15944424van 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.
PubMed 29061270de 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.
PubMed 24144736de 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.
PubMed 24037566De 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.
PubMed 20484396
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovascular Versus Transabdominal Treatment of the Abdominal Aortic Aneurysm: the Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial
- ClinicalTrials.gov ID
- NCT00421330
- Acronym / sponsor ID
- 00/144
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- Abdominal aortic aneurysm, AAA, randomised controlled trial, Endovascular repair, conventional open repair
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 392 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Nov 2000
- Study completion
- Dec 2007 (estimated)
- First posted
- 11 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OR | Active comparator | Procedure: Open Aneurysm RepairOpen Aneurysm Repair |
| EVAR | Experimental | Procedure: Endovascular Aneurysm RepairEndovascular Aneurysm Repair |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Aneurysm Repair | Procedure or surgery | OR |
| Endovascular Aneurysm RepairAlso: Excluder, Talent, Zenith, AneuRx | Procedure or surgery | EVAR |
Primary outcome
combined operative mortality and morbidity
Time frame: 5-8 years
3 secondary outcomes
event free survival
Time frame: 5-8 years
quality of life
Time frame: 5-8 years
cost-effectiveness
Time frame: 5-8 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2008.
- Results publication: PubMed 12055570Prinssen 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 publication: PubMed 15483279Prinssen 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 publication: PubMed 14718892Prinssen 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 publication: PubMed 15615551Prinssen 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 publication: PubMed 15944424Blankensteijn 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.
- Derived from this study: PubMed 29061270van 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.
- Derived from this study: PubMed 24144736de 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.
- Derived from this study: PubMed 24037566de 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.
- Derived from this study: PubMed 20484396De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J D Blankensteijn, MD, PhD principal investigator
Radboud University Nijmegen Mecial Center, The Netherlands
Questions about this trial
What is this clinical trial studying?
A study testing Open Aneurysm Repair and Endovascular Aneurysm Repair in people with Abdominal Aortic Aneurysm, run by UMC Utrecht.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
combined operative mortality and morbidity (time frame: 5-8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00421330, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2008.