Thoracoabdominal Aortic Aneurysm
Conditions
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
Safe-line approach
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Italy