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/39069017/Actively Recruiting
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-03-18
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
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 stenta metal mesh tube with a fabric layeris 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
Mid- and Long-term Outcomes of Custom-made Aortic Devices
G
Giovanni Tinelli
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead Sponsor
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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)
Duration - Up to 3 years
Participants are followed to monitor outcomes after the TEVAR procedure.
Regular follow-up visits over 3 years
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Simona Sica, Giovanni Pratesi, Giovanni Rossi...
https://pubmed.ncbi.nlm.nih.gov/39069017/Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead Sponsor