Phase 4
N=881
Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA)
Aortic Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT00094575 ↗Enrolled (actual)
881
Serious AEs
75.5%
Results posted
Dec 2013
Primary outcome: Primary: All-cause Mortality — 146; 146 participants — p=0.81
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Endovascular Repair (Procedure); Standard Open Repair (Procedure)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY All-cause Mortality |
146; 146 | 0.81 |
| SECONDARY Secondary Therapeutic Procedures |
98; 78 | 0.12 |
| SECONDARY SF-36 Mental Component Score (MCS) |
-0.77; -0.66 | 0.81 |
| SECONDARY SF-36 Physical Component Score (PCS) |
-3.18; -3.05 | 0.80 |
| SECONDARY SF-36 Physical Component Deaths Included Score (PCTD) |
-7.30; -6.98 | 0.78 |
| SECONDARY European Quality of Life-5 Dimension (EQ-5D) Index Score |
-3.67; -3.17 | 0.58 |
| SECONDARY European Quality of Life-5 Dimension (EQ-5D) Visual Analog Scale |
-0.04; -0.03 | 0.37 |
| SECONDARY International Index of Erectile Function (IIEF-5) |
-3.54; -3.73 | 0.68 |
Summary
A multi-center, randomized clinical trial that will compare endovascular repair with standard open surgery in the repair of abdominal aortic aneurysms (AAA). Long and short-term results as well as the cost and quality of life associated with these two strategies for AAA repair will be compared.
Eligibility Criteria
Inclusion Criteria
- AAA with a maximum external diameter in any plane greater than or equal to 5 cm.
- An iliac aneurysm (associated with an AAA) with a maximum external diameter in any plane greater than or equal to 3 cm.
- AAA greater than or equal to 4.5 cm and the AAA has increased by greater than or equal to 0.7 cm in diameter in 6 months.
- An AAA greater than or equal to 4.5 cm and the AAA has increased by greater than or equal to 1 cm in diameter in 12 months.
- An AAA greater than or equal to 4.5 cm and the AAA is saccular (i.e., a portion of the circumference of the aorta at the level of the aneurysm is considered normal based on CT scan or MRI).
- An AAA greater than or equal to 4.5 cm and the AAA is associated with distal embolism.
- as measured from two imaging studies (ultrasound CT scan or MRI) within the appropriate interval, the later one within 6 months of randomization.
Exclusion Criteria
- Patient has had a previous AAA repair procedure
- Evidence of AAA rupture by imaging test
- AAA is not elective (i.e., urgent or emergent operation, usually due to suspected rupture)
- Likelihood of poor compliance to the protocol
- Patient refused randomization
- Physician refused randomization
Data sourced from ClinicalTrials.gov (NCT00094575). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.