Infra Renal Aortic Aneurysm Clinical Trial
— PRSOfficial 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
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.
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | C.H.U De Nancy | Nancy | |
| Italy | Policlinico S. Orsola-Malpighi | Bologna | |
| United States | University Hospital Case Medical Center | Cleveland | Ohio |
| United States | Riverside Methodist Hospital | Columbus | Ohio |
| United States | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Simbionix US Corporation |
United States, France, Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Fluoro time | Within 4 hr. after EVAR procedure starts | Yes | |
| Primary | Subjective operator perceived effectiveness of prior procedure rehearsal | Within 4 hr. after EVAR procedure starts | No | |
| Secondary | 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 | Yes |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | Gate cannulation time | Time to cannulate the contralateral gate with a wire. | Within 3 hr. after EVAR procedure starts | Yes |
| Secondary | Similarity of simulation to actual case | Anatomy Anticipated devices (sizing, tools) Fluoroscopic Angulations Case complexity |
Within 3 hr. after EVAR procedure ends | No |
| Secondary | General satisfaction- Subjective experience of simulation experience | Overall ease of use Controls Imaging Device exchanges Device performance |
Within 4 hr. after EVAR procedure ends | No |
| Secondary | Cost analysis | Within the first 30 days after the EVAR procedure | No | |
| Secondary | Technical/Clinical success rate | Successful endograft deployment and absence of type 1 or 3 endoleak | Within the first 30 days after the EVAR procedure | Yes |
| Secondary | Time of simulator rehearsal | Within 3 hr. after EVAR procedure rehearsal ends | No | |
| Secondary | Time in ICU | within 30 days after the EVAR procedure | Yes | |
| Secondary | Overall Length of Stay | Within 30 days after the EVAR procedure | Yes |