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Minima Stent System Post- Approval Study (PAS)

Participate in Minima Stent System study, trained till October 2023.

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Phase N/A
Study Summary: This study is for people receiving a special device called the Renata Minima Stent System, used to help open blocked blood vessels. It's a Post-Approval Study, which means checking how well the device works after it's been approved for use. To be part of the study, at least 100 people will need to join. How It Works: After the stent is put in, participants will have regular check-ups right after the procedure, then at times when the stent might need to be adjusted, every year, and any other times the doctor thinks necessary, for up to 5 years. The data collected will help understand how well the device works in real life. Eligibility: To join, the participant's representative must agree to the study and sign a consent form. The participant should be suitable for the Minima Stent System. Some people can't join, like those with infections, certain heart issues, or certain body conditions, and those allergic to specific medicines or materials used in the procedure.
  • This study lasts up to 5 years with multiple follow-up visits.
  • The study will include at least 100 participants.
  • Participants need to be suitable for the stent and not have certain conditions.
Study details
    Pulmonary Artery Stenosis
    Aortic Coarctation

NCT06828770

Renata Medical

15 August 2026

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