The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Exclusion of TAAA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: safe-line technique.
- Who it may be relevant to
- Registry conditions: Thoracoabdominal Aortic Aneurysm. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Thoraco-abdominal Aneurysm Repair
Overview
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
- Procedure safe-line technique
Safe-line approach
Primary outcome measures
- Incidence of adverse events [Time frame: 7 days]
- Incidence of spinal cord ischemia improvement or resolution [Time frame: 30 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Italy · 1 center
- Vascular and Endovascular Clinic - Padova University — Padova
Identifiers
NCT: NCT05758844 · Safe-line.1