Minima stent system long-term safety study
Part of Genetic & congenital, Heart & circulation clinical trials.
This study checks the safety of the Minima Stent System over time. It is for people who need a stent to keep their blood vessel open. The study wants to see how the device works in real-world use.
Summary written for real people, not researchers, by Clin2.
Who can take part
- The patient or their legal guardian must agree to the study and sign a consent form.
- The patient must be approved for the Minima Stent System based on the device instructions.
- No active bloodstream infection needing antibiotics within the last 3 days before the procedure.
- No history of infection inside the heart (endocarditis) needing treatment in the last 6 months.
- No aneurysm (bulging weak spot) in the aorta or pulmonary artery where the stent will go.
- The patient must weigh at least 1.5 kg (about 3.3 pounds).
- The narrowed blood vessel must be the right size for the Minima stent balloon.
- No genetic condition known to cause blood vessel problems (like Williams syndrome or Loeys-Dietz syndrome).
- Only one blood vessel needs a stent during this procedure, not more than one.
- The patient cannot be in any other drug or device study right now.
- The patient is not expected to live less than 6 months due to other major diseases.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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