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

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.

Study Overview

• Status: Unknown
• Conditions: Infra Renal Aortic Aneurysm

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• France
  • Nancy, France
    • Recruiting
    • C.H.U De Nancy
    • Contact: Nicla Settembre, Md
    • Principal Investigator: Nicla Settembre, MD
• Italy
  • Bologna, Italy
    • Recruiting
    • Policlinico S. Orsola-Malpighi
    • Contact: Mauro Gargiulo, MD
    • Principal Investigator: Mauro Gargiulo, MD
• United States
  • Florida
    • Miami, Florida, United States
      • Recruiting
      • Baptist Cardiac and Vascular Institute
      • Contact: Barry T Katzen, MD
      • Contact: Constantino Pena, MD
      • Principal Investigator: Barry T Katzen, MD
    • Tampa, Florida, United States
      • Recruiting
      • University of South Florida, Tampa General Hospital
      • Contact: Murray L Shames, MD
      • Principal Investigator: Murray L Shames, MD
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Recruiting
      • Holy Name Medical Center
      • Contact: John H. Rundback, MD; Phone Number: 201-833-7268; Email: jrundback@airsllp.com
      • Contact: Ravit Barkama, MD; Phone Number: 201-541-6312; Email: barkama@mail.holyname.org
      • Principal Investigator: John H. Rundback, MD
  • Ohio
    • Cleveland, Ohio, United States
      • Recruiting
      • University Hospital Case Medical Center
      • Contact: Henry R Baele, MD
      • Principal Investigator: Henry R Baele, MD
    • Columbus, Ohio, United States
      • Recruiting
      • Riverside Methodist Hospital
      • Contact: Gary M Ansel, MD
      • Principal Investigator: Gary M Ansel, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects admitted for elective endovascular AAA repair will be randomized

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control group; Procedure/Surgery : Endovascular Aneurysm Repair with no prior procedure rehearsal
Rehearsal group; Procedure/Surgery : Endovascular Aneurysm Repair with prior procedure rehearsal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraprocedural safety measurements	Overall contrast use (volume); Skin entry radiation dose; 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); Procedural blood loss - number of transfused units; Arterial injury (dissection, perforation, rupture, surgical conversion, embolization, none)	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	Anatomy; Anticipated devices (sizing, tools); Fluoroscopic Angulations; Case complexity	Within 3 hr. after EVAR procedure ends
General satisfaction- Subjective experience of simulation experience	Overall ease of use; Controls; Imaging; Device exchanges; Device performance	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

Collaborators and Investigators

• Sponsor: Simbionix US Corporation
• Investigators: Principal Investigator: John H. Rundback, MD, Holy Name Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2015

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: May 28, 2014
• First Posted (Estimate): June 2, 2014

Study Record Updates

• Last Update Posted (Estimate): June 17, 2015
• Last Update Submitted That Met QC Criteria: June 16, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: elective endovascular AAA repair
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm
• Other Study ID Numbers: PRS-001