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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Procedure/Surgery : Endovascular Aneurysm Repair with no prior procedure rehearsal | ||
| Rehearsal group | Procedure/Surgery : Endovascular Aneurysm Repair with prior procedure rehearsal |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Fluoro time | Within 4 hr. after EVAR procedure starts | |
| Subjective operator perceived effectiveness of prior procedure rehearsal | Within 4 hr. after EVAR procedure starts |
| Measure | Description | Time Frame |
|---|---|---|
| Intraprocedural safety measurements |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects admitted for elective endovascular AAA repair will be randomized
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erez Ben Zvi | Contact | +972 54 669 0924 | erez.benzvi@3Dsystems.com |
| Name | Affiliation | Role |
|---|---|---|
| John H. Rundback, MD | Holy Name Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baptist Cardiac and Vascular Institute | Recruiting | Miami | Florida | United States |
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| Within 4 hr. after EVAR procedure starts |
| Change in procedure plan | Comparison of treatment plans based on Customary (normal institutional) technique, following 3D reconstruction, and after simulation procedures. | Within 4 hr. after EVAR procedure rehearsal starts |
| Adjunctive device utilization | Number and type of used wires, catheters, stent grafts, additional stent graft components and balloons | Within 4 hr. after EVAR procedure ends |
| Gate cannulation time | Time to cannulate the contralateral gate with a wire. | Within 3 hr. after EVAR procedure starts |
| Similarity of simulation to actual case |
| Within 3 hr. after EVAR procedure ends |
| General satisfaction- Subjective experience of simulation experience |
| Within 4 hr. after EVAR procedure ends |
| Cost analysis | Within the first 30 days after the EVAR procedure |
| Technical/Clinical success rate | Successful endograft deployment and absence of type 1 or 3 endoleak | Within the first 30 days after the EVAR procedure |
| Time of simulator rehearsal | Within 3 hr. after EVAR procedure rehearsal ends |
| Time in ICU | within 30 days after the EVAR procedure |
| Overall Length of Stay | Within 30 days after the EVAR procedure |
| University of South Florida, Tampa General Hospital | Recruiting | Tampa | Florida | United States |
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| Holy Name Medical Center | Recruiting | Teaneck | New Jersey | 07666 | United States |
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| University Hospital Case Medical Center | Recruiting | Cleveland | Ohio | United States |
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| Riverside Methodist Hospital | Recruiting | Columbus | Ohio | United States |
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| C.H.U De Nancy | Recruiting | Nancy | France |
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| Policlinico S. Orsola-Malpighi | Recruiting | Bologna | Italy |
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