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

• Conditions: Infra Renal Aortic Aneurysm

• Registration Number: NCT02151942
• Lead Sponsor: Simbionix US Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-06-02
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-16
• Last Update Posted: 2015-06-17
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Cost analysis	Within the first 30 days after the EVAR procedure
Change in procedure plan	Within 4 hr. after EVAR procedure rehearsal starts	Comparison of treatment plans based on Customary (normal institutional) technique, following 3D reconstruction, and after simulation procedures.
Adjunctive device utilization	Within 4 hr. after EVAR procedure ends	Number and type of used wires, catheters, stent grafts, additional stent graft components and balloons
Time of simulator rehearsal	Within 3 hr. after EVAR procedure rehearsal ends
Technical/Clinical success rate	Within the first 30 days after the EVAR procedure	Successful endograft deployment and absence of type 1 or 3 endoleak
Intraprocedural safety measurements	Within 4 hr. after EVAR procedure starts	1. Overall contrast use (volume); 2. Skin entry radiation dose; 3. Overall procedure time (from gaining bilateral access until the satisfactory completion of endograft deployment, excluding all adjunctive procedures such as hypogastric embolization, Iliac Percutaneous Transluminal Angioplasty (PTA)/Stenting, sheath removal and hemostasis time); 4. Procedural blood loss - number of transfused units; 5. Arterial injury (dissection, perforation, rupture, surgical conversion, embolization, none)
Gate cannulation time	Within 3 hr. after EVAR procedure starts	Time to cannulate the contralateral gate with a wire.
Similarity of simulation to actual case	Within 3 hr. after EVAR procedure ends	1. Anatomy; 2. Anticipated devices (sizing, tools); 3. Fluoroscopic Angulations; 4. Case complexity
General satisfaction- Subjective experience of simulation experience	Within 4 hr. after EVAR procedure ends	1. Overall ease of use; 2. Controls; 3. Imaging; 4. Device exchanges; 5. Device performance
Time in ICU	within 30 days after the EVAR procedure
Overall Length of Stay	Within 30 days after the EVAR procedure

Trial Locations

Locations (7)

Baptist Cardiac and Vascular Institute; 🇺🇸 Miami, Florida, United States

University of South Florida, Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Holy Name Medical Center; 🇺🇸 Teaneck, New Jersey, United States

University Hospital Case Medical Center; 🇺🇸 Cleveland, Ohio, United States

Riverside Methodist Hospital; 🇺🇸 Columbus, Ohio, United States

C.H.U De Nancy; 🇫🇷 Nancy, France

Policlinico S. Orsola-Malpighi; 🇮🇹 Bologna, Italy