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

NCT ID: NCT05758844

Last Updated: 2023-03-08

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2026-12-01

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.

Conditions

Thoracoabdominal Aortic Aneurysm

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

safe-line technique

Safe-line approach

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Padova

OTHER

Sponsor Role: lead

Responsible Party

Michele Piazza

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Vascular and Endovascular Clinic - Padova University

Padua, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Michele Piazza, Pr.

Role: CONTACT

michele.piazza@unipd.it

3498644688

Francesco Squizzato, MD

Role: CONTACT

francesco.squizzato@yahoo.it

Facility Contacts

Michele Piazza, Pr

Role: primary

michele.piazza@unipd.it

3498644688

Other Identifiers

Safe-line.1

Identifier Type: -

Identifier Source: org_study_id