RecruitingPulmonary Artery StenosisAortic Coarctation

Minima Stent System Post- Approval Study (PAS)

Eligible age

All ages

Accepts

All genders

Locations

13 states

Healthy volunteers

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About this study

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.

Sponsor: Renata Medical

You may qualify if…

✓ 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.

You may not qualify if…

✕ Active bloodstream infection requiring antibiotic therapy within 3 days prior to stent implantation
✕ History of or active endocarditis (active treatment with antibiotics) within 180 days prior to stent implantation
✕ Aortic or pulmonary artery aneurysm in the location targeted for treatment
✕ Body weight \< 1.5 kg
✕ Anatomic location of lesion judged by the investigator to not lend to the safe placement of a stent
✕ Target vessels larger or smaller than the Minima System balloon size ranges
✕ Known genetic syndrome known to be associated with vasculopathies such as but not limited to Williams syndrome, Loeys-Dietz syndrome, etc
✕ Clinical scenario requiring that more than one vessel needs stent implantation at the time of the trial procedure.