Patient-Specific Simulation Used for EVAR Procedure Rehearsal - Evaluation of Clinical Performance With and Without Prior Rehearsal
Status unconfirmed
Conditions studied: Infra Renal Aortic Aneurysm
In brief
The purpose of this study is to evaluate the procedural and clinical benefits of patient specific pre-procedure rehearsal for operators with various experience levels as a tool for optimizing Endovascular Aneurysm Repair (EVAR) procedures.
Key facts
- Study ID
- NCT02151942
- Run by
- Simbionix US Corporation
- People needed
- 150
- Starts
- 2013-06-01
- Expected to finish
- 2015-12-01
- Last updated by the study team
- 2015-06-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- At least 18 years old
- Elective patients planned to undergo EVAR procedures with an endograft compatible with the Simbionix PRS.
- Computed Tomography Angiography (CTA) scan of the abdominal aorta performed as standard of care. Sufficient quality/defined protocol.
You may not qualify if…
- Subject is below 18 years old
- Operator cannot complete the indicated rehearsal and practice.
- Patients requiring emergent aneurysm treatment, e.g. trauma or rupture.
- Arterial dissection.
- Patients with Stage 4 of chronic kidney disease (GFR<30 ml/min/m2).
- Patient is indicated for use of snorkels, chimneys, fenestrated or branched graft devices
- Pregnant or lactating women.
- Off label stent graft use
Where it is running
- Baptist Cardiac and Vascular Institute — Miami, Florida, United States (enrolling)
- University of South Florida, Tampa General Hospital — Tampa, Florida, United States (enrolling)
- Holy Name Medical Center — Teaneck, New Jersey, United States (enrolling)
- University Hospital Case Medical Center — Cleveland, Ohio, United States (enrolling)
- Riverside Methodist Hospital — Columbus, Ohio, United States (enrolling)
- C.H.U De Nancy — Nancy, France (enrolling)
- Policlinico S. Orsola-Malpighi — Bologna, Italy (enrolling)
Full record on ClinicalTrials.gov
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