Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endovascular Versus Transabdominal Treatment of the Abdominal Aortic Aneurysm: the Dutch Randomised Endovascular Aneurysm Management (DREAM-) Trial

Conditions
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Abdominal Aortic Aneurysm

Intervention / Treatment
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* Procedure: Open Aneurysm Repair
* Procedure: Endovascular Aneurysm Repair


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OR<br>Open Aneurysm Repair | Procedure: Open Aneurysm Repair<br> <br> |
| Experimental: EVAR<br>Endovascular Aneurysm Repair | Procedure: Endovascular Aneurysm Repair<br> <br> * Other names: Excluder, Talent, Zenith, AneuRx;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| combined operative mortality and morbidity |  | 5-8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| event free survival |  | 5-8 years | 
| quality of life |  | 5-8 years | 
| cost-effectiveness |  | 5-8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Abdominal aortic aneurysm, AAA, randomised controlled trial, Endovascular repair, conventional open repair