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

University Hospital Padova

Status: Enrolling

Conditions: Thoracoabdominal Aortic Aneurysm

Treatments: Procedure: safe-line technique

Study type: Observational

Funder types: Other

Identifiers

NCT05758844

Safe-line.1

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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