Clinical trial NCT02151942: Patient-Specific Simulation Used for EVAR Procedure Rehearsal - Evaluation of Clinical Performance With and Without Prior Rehearsal
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infra Renal Aortic Aneurysm
Keywords: elective endovascular AAA repair
Lead sponsor: Simbionix US Corporation
Sponsor class: INDUSTRY
First posted: 2014-06-02
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects admitted for elective endovascular AAA repair will be randomized

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.


Eligibility criteria: 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

Primary outcomes:
measure: Overall Fluoro time
timeFrame: Within 4 hr. after EVAR procedure starts
measure: Subjective operator perceived effectiveness of prior procedure rehearsal
timeFrame: Within 4 hr. after EVAR procedure starts
Secondary outcomes:
measure: Intraprocedural safety measurements
timeFrame: Within 4 hr. after EVAR procedure starts
measure: Change in procedure plan
timeFrame: Within 4 hr. after EVAR procedure rehearsal starts
measure: Adjunctive device utilization
timeFrame: Within 4 hr. after EVAR procedure ends
measure: Gate cannulation time
timeFrame: Within 3 hr. after EVAR procedure starts
measure: Similarity of simulation to actual case
timeFrame: Within 3 hr. after EVAR procedure ends
measure: General satisfaction- Subjective experience of simulation experience
timeFrame: Within 4 hr. after EVAR procedure ends
measure: Cost analysis
timeFrame: Within the first 30 days after the EVAR procedure
measure: Technical/Clinical success rate
timeFrame: Within the first 30 days after the EVAR procedure
measure: Time of simulator rehearsal
timeFrame: Within 3 hr. after EVAR procedure rehearsal ends
measure: Time in ICU
timeFrame: within 30 days after the EVAR procedure
measure: Overall Length of Stay
timeFrame: Within 30 days after the EVAR procedure
Other outcomes:
Locations:
city: Miami
country: United States
facility: Baptist Cardiac and Vascular Institute
state: Florida
city: Tampa
country: United States
facility: University of South Florida, Tampa General Hospital
state: Florida
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Cleveland
country: United States
facility: University Hospital Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Nancy
country: France
facility: C.H.U De Nancy
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi
Study officials:
affiliation: Holy Name Medical Center
name: John H. Rundback, MD
role: PRINCIPAL_INVESTIGATOR
References: