Minima Stent System Post- Approval Study (PAS)

Recruiting now

Conditions studied: Pulmonary Artery Stenosis, Aortic Coarctation

In brief

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.

Key facts

Study ID

NCT06828770

Run by

Renata Medical

People needed

100

Starts

2025-05-21

Expected to finish

2031-12-01

Last updated by the study team

2025-10-23

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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.
• 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 it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States (enrolling)
• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
• Nicklaus Children's Hospital — Miami, Florida, United States (enrolling)
• Children's Healthcare of Atlanta — Atlanta, Georgia, United States (enrolling)
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (enrolling)
• Riley Hospital for Children at Indiana University Health — Indianapolis, Indiana, United States (enrolling)
• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• Washington University — Saint Louis, Michigan, United States (enrolling)
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States (enrolling)
• Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States (enrolling)
• Dell Children's Medical Center, The University of Texas at Austin — Austin, Texas, United States (enrolling)
• Columbia Hospital at Medical City Dallas Hospital — Dallas, Texas, United States (enrolling)
• UVA Health Children's Hospital — Charlottesville, Virginia, United States (enrolling)
• Seattle Children's Hospital — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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