Patient-Specific Simulation Used for EVAR Procedure Rehearsal - Evaluation of Clinical Performance With and Without Prior Rehearsal

Status:	Completed
Conditions:	Cardiology, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	4/2/2016
Start Date:	June 2013
End Date:	December 2015
Contact:	Erez Ben Zvi
Email:	erez.benzvi@3Dsystems.com
Phone:	+972 54 669 0924

Patient-Specific Simulation Used for Case Rehearsal Prior to EVAR Procedure - Evaluation of Clinical Performance With and Without Prior Rehearsal Using the Procedure Rehearsal Studio. Multi-center Randomized Study

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.

Inclusion Criteria:

1. At least 18 years old

2. Elective patients planned to undergo EVAR procedures with an endograft compatible
with the Simbionix PRS.

3. Computed Tomography Angiography (CTA) scan of the abdominal aorta performed as
standard of care. Sufficient quality/defined protocol.

Exclusion Criteria:

1. Subject is below 18 years old

2. Operator cannot complete the indicated rehearsal and practice.

3. Patients requiring emergent aneurysm treatment, e.g. trauma or rupture.

4. Arterial dissection.

5. Patients with Stage 4 of chronic kidney disease (GFR<30 ml/min/m2).

6. Patient is indicated for use of snorkels, chimneys, fenestrated or branched graft
devices

7. Pregnant or lactating women.

8. Off label stent graft use

We found this trial at

sites

University Hospital Case Medical Center

Cleveland, Ohio 44106

from

Cleveland, OH