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To assess safety and feasebility of the "safe-line" technique in a multicenter international collaboration.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| safe-line technique | Procedure | Safe-line approach |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | collect eventual complications (incidence of: 1- axis thrombosis; 2- microembolization; 3-hematoma) | 7 days |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-thoraco-abdominal aortic aneurysm open repair
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Inclusion of all patients treated for thoraco abdominal aortic aneurysm with endovascular repair and use of safe line technique
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michele Piazza, Pr. | Contact | 3498644688 | michele.piazza@unipd.it | |
| Francesco Squizzato, MD | Contact | francesco.squizzato@yahoo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vascular and Endovascular Clinic - Padova University | Recruiting | Padova | 35020 | Italy |
With other partecipating centers
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| ID | Term |
|---|---|
| D000094624 | Aortic Aneurysm, Thoracoabdominal |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
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| D002318 |
| Cardiovascular Diseases |
| D001018 | Aortic Diseases |