N/A Completed N=613 Randomized Treatment

Immediate Management of the Patient With Rupture : Open Versus Endovascular Repair

Abdominal aortic aneurysm

Source: ClinicalTrials.gov NCT00746122 ↗

Enrolled (actual)

613

Serious AEs

39.5%

Results posted

Dec 2019

Primary outcomePrimary: Mortality — 111; 112; 133; 130 Participants

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).

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	—

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.

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.