NCT06828770 · Renata Medical
Minima Stent System Post- Approval Study (PAS)
What this study is about
This Post-Approval Study is a single treatment group$1, forward-looking, multi-center, where both patients and doctors know the treatment given 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
- Aurora, Colorado
- Miami, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Indianapolis, Indiana
- Boston, Massachusetts
- Saint Louis, Michigan
- Cincinnati, Ohio
- Columbus, Ohio
- Pittsburgh, Pennsylvania
- Austin, Texas
And 3 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 23, 2025 · Source of record for eligibility and locations