CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 881 enrolled
Drug / intervention
Endovascular Repair +1 moreprocedure
Likely dose
Not stated in record
Key inclusion· 6
  • ✓AAA with maximum external diameter ≥5 cm in any plane
  • ✓Associated iliac aneurysm with maximum external diameter ≥3 cm
  • ✓AAA ≥4.5 cm with growth ≥0.7 cm in 6 months
  • ✓AAA ≥4.5 cm with growth ≥1 cm in 12 months
Key exclusion· 5
  • ✕Previous AAA repair procedure
  • ✕Evidence of AAA rupture on imaging
  • ✕Non-elective operation (urgent or emergent, usually for suspected rupture)
  • ✕Likelihood of poor protocol compliance

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00094575
NCT00094575Phase 4Completed
CompareCT.gov

CSP #498 - Open Versus Endovascular Repair (OVER) Trial for Abdominal Aortic Aneurysms

VA Office of Research and Development·interventional·Posted Oct 21, 2004·Updated Mar 7, 2016

In Brief

A Phase 4 clinical trial evaluating Endovascular Repair and Standard Open Repair for Aortic Aneurysm. Completed, enrolled 881 participants across 42 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Aneurysm
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 21, 2004
Enrollment StartOct 1, 2002
Primary CompletionOct 1, 2011
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 9 yearsPosted 21.7 years ago

Interventions

Endovascular Repairprocedure

Endovascular Repair

Standard Open Repairprocedure

Standard Open Repair