Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2025-05-21
2031-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Minima PAS Patients
Those treated with the Renata Minima Stent System
Minima 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.
Interventions
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Minima 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.
Eligibility Criteria
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Inclusion Criteria
* Indicated for treatment with the Minima Stent System per the IFU.
Exclusion Criteria
* 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
ALL
No
Sponsors
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Renata Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Arash Salavitabar, MD
Role: PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital
Locations
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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
Countries
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Central Contacts
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Renata Medical Corporate
Role: CONTACT
Other Identifiers
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PTC-0038
Identifier Type: -
Identifier Source: org_study_id
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