The Safe-line Technique as Additional Attempt to Mitigate Spinal Cord Ischemia After Endovascular Exclusion of TAAA
Safe-line-tech
1 other identifier
observational
100
1 country
1
Brief Summary
To assess safety and feasebility of the "safe-line" technique in a multicenter international collaboration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2023
CompletedFirst Posted
Study publicly available on registry
March 8, 2023
CompletedStudy Start
First participant enrolled
April 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedMarch 8, 2023
March 1, 2023
2.6 years
January 30, 2023
March 4, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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
Interventions
Safe-line approach
Eligibility Criteria
Inclusion of all patients treated for thoraco abdominal aortic aneurysm with endovascular repair and use of safe line technique
You may qualify if:
- 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
You may not qualify if:
- thoraco-abdominal aortic aneurysm open repair
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vascular and Endovascular Clinic - Padova University
Padua, 35020, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 30, 2023
First Posted
March 8, 2023
Study Start
April 30, 2023
Primary Completion
December 1, 2025
Study Completion (Estimated)
December 1, 2026
Last Updated
March 8, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will share
With other partecipating centers