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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 Thoraco-abdominal Aneurysm Repair

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05758844
Acronym
Safe-line-tech
Enrollment
100
Registered
2023-03-08
Start date
2023-04-30
Completion date
2026-12-01
Last updated
2023-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracoabdominal Aortic Aneurysm

Brief 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.

Interventions

PROCEDUREsafe-line technique

Safe-line approach

Sponsors

University Hospital Padova
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of adverse events7 dayscollect eventual complications (incidence of: 1- axis thrombosis; 2- microembolization; 3-hematoma)
Incidence of spinal cord ischemia improvement or resolution30 dayscollect all events that in case of post-operative (48-72hrs) spinal cord ischemia had symptoms mitigation (1-paraplegia improvement; 2 - paraplegia complete resolution)

Countries

Italy

Contacts

Primary ContactMichele Piazza, Pr.
michele.piazza@unipd.it3498644688
Backup ContactFrancesco Squizzato, MD
francesco.squizzato@yahoo.it

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026