Post-Approval Study of the Renata Minima Stent in the Treatment of Vascular Stenoses in Neonates, Infants, and Small Children
Study of an Investigational Stent for Narrowing of Blood Vessels in Young Children
Ryan Alexy, MD
Primary Investigator
Brief description of 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.
Detailed description of study
- A minimum of 100 subjects will be enrolled.
- Follow-up will occur immediately after the initial implant procedure, at subsequent re-dilation procedures, annually, and at any additional standard of care follow-up visits (determined by the implanting physician) through 5 years post-implant.
- Data collected at each follow-up will be used in analysis. This study will monitor key data points related to the device and procedure.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Aortic Coarctation, Pulmonary Artery Stenosis, Riley
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Age: 100 years or below
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Gender: All
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 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.
- Currently participating in an investigational drug study or another device study
- Major or progressive non-cardiac disease resulting in a life expectancy of less than six months
- Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
- Known hypersensitivity to cobalt-chromium or contrast media that cannot be adequately premedicated
This study investigates the use of an investigational stent for treating vascular stenoses, which are narrowings in blood vessels, in neonates, infants, and small children. Vascular stenoses can cause blood flow problems and may need treatment to widen the vessels.
Participants will receive the investigational stent and will have follow-up visits to monitor their health and the stent's performance. Follow-ups include re-dilation procedures and regular check-ups to gather data for analysis.
- Who can participate: Children eligible for the investigational stent, with legal guardian consent, can participate. Exclusions include recent infections, certain genetic conditions, and weight under 1.5 kg.
- Study details: Participants will receive the investigational stent. The study will monitor the performance of the stent and any procedures related to its use.
- Study timelines: The study will last 5 years.
