The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Thoraco-abdominal Aneurysm Repair
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital Padova
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Incidence of adverse events
Study Overview
Brief Summary
To assess safety and feasebility of the "safe-line" technique in a multicenter international collaboration.
Detailed Description
To assess safety and efficacy of a technique for temporary aneurysm sac re-perfusion (TASreP) after total endovascular exclusion of TAAA, using a guide-wire left into the aneurysm sac. The technique can be applied both in elective that urgent cases.
The guide-wire aim to be a "safe-line" for fast temporary trans-sealing aneurysm sac re-perfusion in case of SCI occurring in the early post-operative period (48-to 72h).
Before completing exclusion, from the percutaneous femoral access, a second buddy-wire (V-18 guidewire; Boston Scientific) is advanced and left posterior to the endograft into the aneurysmal sac; through the main guide-wire, the final aneurysm exclusion is completed with distal stent-graft deployment and the femoral access sealed with Proglide leaving in place the sole V.018 draped in a sterile fashion. In the case of SCI occurrence in the post-operative period up to 48-72 hrs, the trans-sealing V.18 "safe-line" can be rapidly exchanged with a 6F/65 cm long Destination cm guiding sheath (Terumo) and positioned into the aneurysmal sac; this can be connected to a 6F introducer from the contralateral femoral artery and the sac perfused in a retrograde fashion.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Thoraco-abdominal aortic aneurysm including type I,II,III,IV and V.
- •Pararenale aneurysm
- •Thoracoabdominal aortic aneurysm Elective and Urgent, endovascular repair;
- •Endovascular repair of any thoracoabdominal aortic condition
Exclusion Criteria
- •thoraco-abdominal aortic aneurysm open repair
Outcomes
Primary Outcomes
Incidence of adverse events
Time Frame: 7 days
collect eventual complications (incidence of: 1- axis thrombosis; 2- microembolization; 3-hematoma)
Incidence of spinal cord ischemia improvement or resolution
Time Frame: 30 days
collect all events that in case of post-operative (48-72hrs) spinal cord ischemia had symptoms mitigation (1-paraplegia improvement; 2 - paraplegia complete resolution)
Secondary Outcomes
No secondary outcomes reported
Investigators
Michele Piazza
Associate Professor
University Hospital Padova