NCT05758844

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: University Hospital Padova · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thoracoabdominal Aortic Aneurysm

Interventions

Type	Name	Description
PROCEDURE	safe-line technique	Safe-line approach

Timeline

• Start date: 2023-04-30
• Primary completion: 2025-12-01
• Completion: 2026-12-01
• First posted: 2023-03-08
• Last updated: 2023-03-08

Locations

1 site across 1 country: Italy