RecruitingNCT06828770

Minima Stent System Post- Approval Study (PAS)

Post-Approval Study of the Renata Minima Stent in the Treatment of Vascular Stenoses in Neonates, Infants, and Small Children


Sponsor

Renata Medical

Enrollment

100 participants

Start Date

May 21, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Inclusion Criteria2

  • 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 Criteria12

  • 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

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Interventions

DEVICEMinima Stent System

Minima Stent System is indicated for use in the treatment of native or acquired pulmonary artery stenoses or coarctation of the aorta in neonates, infants, and children at least 1.5kg in weight.


Locations(15)

Children's Hospital Los Angeles

Los Angeles, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Nicklaus Children's Hospital

Miami, Florida, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Riley Hospital for Children at Indiana University Health

Indianapolis, Indiana, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Washington University

Saint Louis, Michigan, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Dell Children's Medical Center, The University of Texas at Austin

Austin, Texas, United States

Columbia Hospital at Medical City Dallas Hospital

Dallas, Texas, United States

UVA Health Children's Hospital

Charlottesville, Virginia, United States

Seattle Children's Hospital

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06828770


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