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

Thoracoabdominal Aortic Aneurysm Clinical Trial

— Safe-line-tech  

Official title:

The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Thoraco-abdominal Aneurysm Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05758844
• Other study ID #: Safe-line.1
• Status: Recruiting
• Start date: April 30, 2023
• Est. completion date: December 1, 2026

Study information

• Verified date: March 2023
• Source: University Hospital Padova
• Contact: Michele Piazza, Pr.
• Phone: 3498644688
• Email: michele.piazza[@]unipd.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2026
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Thoracic
• Ischemia
• Spinal Cord Ischemia
• Thoracoabdominal Aortic Aneurysm

Intervention

Procedure:
• safe-line technique
Safe-line approach

Locations

Country	Name	City	State
Italy	Vascular and Endovascular Clinic - Padova University	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Padova

Country where clinical trial is conducted

Italy, 

Outcome

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