Infra Renal Aortic Aneurysm
Conditions
Keywords
elective endovascular AAA repair
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.
Interventions
None listed
Sponsors
Simbionix US Corporation
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Gate cannulation time | Within 3 hr. after EVAR procedure starts | Time to cannulate the contralateral gate with a wire. |
| Technical/Clinical success rate | Within the first 30 days after the EVAR procedure | Successful endograft deployment and absence of type 1 or 3 endoleak |
| 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 | — |
| Cost analysis | Within the first 30 days after the EVAR procedure | — |
| 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) |
Countries
France, Italy, United States
Contacts
Primary ContactErez Ben Zvi
Outcome results
None listed