Safe-line-tech: The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Exclusion of TAAA
Study Details
Study Description
Brief Summary
To assess safety and feasebility of the "safe-line" technique in a multicenter international collaboration.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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
Outcome Measures
Primary Outcome Measures
- Incidence of adverse events [7 days]
collect eventual complications (incidence of: 1- axis thrombosis; 2- microembolization; 3-hematoma)
- Incidence of spinal cord ischemia improvement or resolution [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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Thoraco-abdominal aortic aneurysm including type I,II,III,IV and V.
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Pararenale aneurysm
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Thoracoabdominal aortic aneurysm Elective and Urgent, endovascular repair;
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Endovascular repair of any thoracoabdominal aortic condition
Exclusion Criteria:
-thoraco-abdominal aortic aneurysm open repair
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vascular and Endovascular Clinic - Padova University | Padova | Italy | 35020 |
Sponsors and Collaborators
- University Hospital Padova
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Safe-line.1