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The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Exclusion of TAAA — Safe-line-tech  

Thoracoabdominal Aortic Aneurysm Clinical Trial

Official title:
The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Thoraco-abdominal Aneurysm Repair

Clinical Trial Summary

To assess safety and feasebility of the "safe-line" technique in a multicenter international collaboration.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05758844
Study type Observational [Patient Registry]
Source University Hospital Padova
Contact Michele Piazza, Pr.
Phone 3498644688
Email michele.piazza@unipd.it
Status Recruiting
Phase
Start date April 30, 2023
Completion date December 1, 2026
View Details
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