Using a new technique to prevent spinal cord damage after aortic aneurysm surgery
The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Thoraco-abdominal Aneurysm Repair
This study is testing a new technique to see if leaving a guide-wire in place during surgery for aortic aneurysms can help prevent spinal cord damage in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital Padova Academic / other |
| Locations | 1 site (Padova) |
| Trial ID | NCT05758844 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and feasibility of the 'safe-line' technique, which involves leaving a guide-wire in the aneurysm sac during endovascular exclusion of thoracoabdominal aortic aneurysms (TAAA). The technique aims to allow for rapid re-perfusion of the aneurysm sac in case of spinal cord ischemia (SCI) occurring within 48 to 72 hours post-surgery. It is applicable in both elective and urgent cases, providing a potential safety net for patients undergoing this complex procedure. The study is conducted as a multicenter international collaboration to gather comprehensive data on its effectiveness.
Who should consider this trial
Good fit: Ideal candidates include patients with thoracoabdominal aortic aneurysms who are undergoing elective or urgent endovascular repair.
Not a fit: Patients who have undergone open repair of thoracoabdominal aortic aneurysms will not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could significantly reduce the risk of spinal cord ischemia in patients undergoing TAAA repair.
How similar studies have performed: While this approach is innovative, similar techniques for managing spinal cord ischemia in aortic surgeries have shown promise in other studies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Padova
- Vascular and Endovascular Clinic - Padova University — Padova, Italy (Recruiting)
Study contacts
- Study coordinator: Michele Piazza, Pr.
- Email: michele.piazza@unipd.it
- Phone: 3498644688
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.