Vascular and Endovascular Clinic - Padova University
Padova, 35020, Italy
Location status: Recruiting
NCT Number: NCT05758844
To assess safety and feasebility of the "safe-line" technique in a multicenter international collaboration.
Interested in participating?
Request Info18 year–100 year
All sexes
Observational
Padova, 35020, Italy
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
-thoraco-abdominal aortic aneurysm open repair
Safe-line approach
Time frame: 7 days
collect eventual complications (incidence of: 1- axis thrombosis; 2- microembolization; 3-hematoma)
Time frame: 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)
Contact information is provided by the study sponsor or research team.
Francesco Squizzato, MD
CONTACT
Michele Piazza, Pr.
CONTACT
University Hospital Padova
Other
The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Thoraco-abdominal Aneurysm Repair
Acronym: Safe-line-tech
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