Recruiting

Patient-Specific Simulation

Sponsor:

Simbionix US Corporation

Code:

NCT02151942

Conditions

Infra Renal Aortic Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Infra Renal Aortic Aneurysm

Study ID

NCT02151942

Start date

Jun, 2013

Status verified date

Jun, 2015

Completion date

Dec, 2015

Anticipated

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

Control group

Procedure/Surgery : Endovascular Aneurysm Repair with no prior procedure rehearsal

Rehearsal group

Procedure/Surgery : Endovascular Aneurysm Repair with prior procedure rehearsal

Primary outcome measure

  • Overall Fluoro time [ Time Frame: Within 4 hr. after EVAR procedure starts ]
  • Subjective operator perceived effectiveness of prior procedure rehearsal [ Time Frame: Within 4 hr. after EVAR procedure starts ]

Central Contacts and Locations

Central contacts

Erez Ben Zvi

+972 54 669 0924erez.benzvi@3Dsystems.com

Locations

Baptist Cardiac and Vascular Institute

Recruiting

Miami, Florida, United States

Principal Investigator:

Barry T Katzen, MD

University of South Florida, Tampa General Hospital

Recruiting

Tampa, Florida, United States

Principal Investigator:

Murray L Shames, MD

Holy Name Medical Center

Recruiting

Teaneck, New Jersey, United States, 07666

Contacts

John H. Rundback, MD

201-833-7268jrundback@airsllp.com

Ravit Barkama, MD

201-541-6312barkama@mail.holyname.org

Principal Investigator:

John H. Rundback, MD

University Hospital Case Medical Center

Recruiting

Cleveland, Ohio, United States

Principal Investigator:

Henry R Baele, MD

Riverside Methodist Hospital

Recruiting

Columbus, Ohio, United States

Principal Investigator:

Gary M Ansel, MD

More Information

Sponsor

Simbionix US Corporation

Last update posted

Jun 17, 2015

Last verified

Jun, 2015

Keywords

  • elective endovascular AAA repair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Simbionix US Corporation on 2015-06-17.