Minima Stent System Post- Approval Study (PAS)

Recruiting Observational Study
Pulmonary Artery Stenosis Aortic Coarctation
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Sex
Any
Study type
Observational
Participants needed
100 (estimated)
Sponsor
Renata Medical · Industry
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About This Trial

This Post-Approval Study is a single arm, prospective, multi-center, open-label study of patients treated with the Renata Minima Stent System in the United States. The objective of the study is to continue the assessment of device performance and capture outcome data on use of the device in real-world use.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * The subject's legally authorized representative has been informed of the nature of the device treatment, agrees to its provisions, and has provided written informed consent * Indicated for treatment with the Minima Stent System per the IFU. Exclusion Criteria: * Active blood…
Contacts

Renata Medical Clinical & Regulatory Affairs

855-318-4988

dali@renatamedical.com

CONTACT

Renata Medical Corporate

949-478-0539

CONTACT