Proximal sealing in the aortic arch for inner curve disease using the custom Relay scalloped and fenestrated stent graft.
Simona Sica, Giovanni Pratesi, Giovanni Rossi...
https://pubmed.ncbi.nlm.nih.gov/39069017Actively Recruiting
Age: 18Years +
All Genders
ID05777460
Results From a Multicenter Registry on the Outcomes of the Terumo Custom-made Aortic Endograft
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-18
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the mid- and long-term results after Thoracic Endovascular Aortic Repair (TEVAR) using custom-made devices. The focus is on outcomes for patients with thoracic aortic diseases, including thoracic aortic aneurysm. The study collects data to better understand survival and complications related to this procedure over time. Participants undergo TEVAR, a procedure where a covered stent—a metal mesh tube with a fabric layer—is placed inside the weakened area of the artery to support it. This study observes patients after this treatment without altering their care, gathering information through a multicenter registry. During the study, researchers track overall mortality and deaths related to the aorta over a period of three years. Patients' health and outcomes are monitored through follow-up assessments to understand the safety and durability of the custom-made aortic devices. The study began in October 2020 and will continue until November 2027.
CONDITIONS
Brief Title
Mid- and Long-term Outcomes of Custom-made Aortic Devices
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of thoracic aortic disease
You will not qualify if you...
- Need for urgent or emergency treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - 1 day
Participants undergo the thoracic endovascular aortic repair (TEVAR) procedure involving placement of a covered stent into the weakened area of the artery.
1 procedure visit (in-person)
Post-operative Follow-up
Duration - Up to 3 years
Participants are followed to monitor outcomes after the TEVAR procedure.
Regular follow-up visits over 3 years
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, Italy, 00167
Actively Recruiting
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Research Team
G
Giovanni Tinelli
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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