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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 Exclusion of TAAA

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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.

Eligibility

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

Study details
    Thoracoabdominal Aortic Aneurysm

NCT05758844

University Hospital Padova

27 January 2024

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