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

Recruiting

• Conditions: Thoracoabdominal Aortic Aneurysm

• Registration Number: NCT05758844
• Lead Sponsor: University Hospital Padova

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.

Study Timeline

• Study First Submitted: 2023-01-30
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-04
• Last Update Submitted: 2023-03-04
• Study First Posted: 2023-03-08
• Last Update Posted: 2023-03-08
• Study Start: 2023-04-30
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

-thoraco-abdominal aortic aneurysm open repair

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events	7 days	collect eventual complications (incidence of: 1- axis thrombosis; 2- microembolization; 3-hematoma)
Incidence of spinal cord ischemia improvement or resolution	30 days	collect all events that in case of post-operative (48-72hrs) spinal cord ischemia had symptoms mitigation (1-paraplegia improvement; 2 - paraplegia complete resolution)

Trial Locations

Locations (1)

Vascular and Endovascular Clinic - Padova University; 🇮🇹 Padova, Italy