N/A
N=613
Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair
Abdominal Aortic Aneurysm
Bottom Line
View on ClinicalTrials.gov: NCT00746122 ↗Enrolled (actual)
613
Serious AEs
39.5%
Results posted
Dec 2019
Primary outcome: Primary: Mortality — 111; 112; 133; 130 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Open repair (Procedure); EVAR (Procedure)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Aug 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality |
111; 112; 133; 130; 165; 151 | — |
| SECONDARY Quality-adjusted Life Years (QALYs) to Enable Cost-effectiveness Evaluation |
0.97; 1.14 | — |
| SECONDARY Hospital Costs to Enable Cost-effectiveness Evaluation |
19483; 16878 | — |
Summary
The purpose of this trial is to assess whether a strategy of endovascular repair (if aortic morphology is suitable, open repair if not) versus open repair reduces early mortality for patients with suspected ruptured abdominal aortic aneurysm (AAA).
Eligibility Criteria
Inclusion Criteria
- Clinical suspicion of ruptured abdominal aortic aneurysm after review in Accident and Emergency (or other hospital unit).
- Men and women over the age of 50 years will be recruited.
Exclusion Criteria
- Patients with known connective tissue disorders (eg Marfan syndrome) where endovascular repair may not be beneficial.
- Patients with known previous repair of an abdominal aortic aneurysm, because procedures either open or endovascular are likely to be very complex and there are no guidelines for anatomical restriction to repair.
- Deeply unconscious and moribund patients since the chances of recovery are minimal.
Data sourced from ClinicalTrials.gov (NCT00746122). 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.