Open Repair Versus Branched Endograft Repair for Treatment of Residual Chronic Aortic Arch Dissection During Follow-up After Open Type A Acute Ascending Aorta Replacement: Results From an International Multicenter Study.
1 other identifier
observational
170
1 country
1
Brief Summary
This study aims to evaluate peri-operative mortality and main post-operative complications (for example cardiovascular, respiratory and renal) in patients treated with frozen elephant trunk techinque.
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 Aug 2019
Longer than P75 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
July 9, 2019
CompletedFirst Posted
Study publicly available on registry
July 10, 2019
CompletedStudy Start
First participant enrolled
August 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMarch 19, 2025
March 1, 2025
3.8 years
July 9, 2019
March 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Peri-operatory mortality
36 months
Secondary Outcomes (1)
Post-operatory complications
36 months
Interventions
Endovascular technique forTAA repair
Eligibility Criteria
Patients undergoing endovascular TAA repair with Frozen Elephant Trunk Technique
You may qualify if:
- patients with post-dissection arch aneurysm with a maximal aortic diameter \>55mm or rapid growth (\>10mm/year)
You may not qualify if:
- Emergency setting
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, 00167, Italy
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of the Endovascular Therapies Unit
Study Record Dates
First Submitted
July 9, 2019
First Posted
July 10, 2019
Study Start
August 1, 2019
Primary Completion
May 1, 2023
Study Completion
December 31, 2024
Last Updated
March 19, 2025
Record last verified: 2025-03