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Growth Trial: Study of the Renata Minima Stent
Sponsor: Renata Medical
Summary
The objective of the clinical investigation is to access clinical safety and effectiveness of the Minima Stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis (i.e., coarctation of the aorta and/or pulmonary artery stenosis) who are indicated for treatment.
Official title: GROWTH: A Multicenter Pivotal Study of Neonatal, Infant, and Young Child Vascular Stenoses Studying the Renata Minima Stent
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
42
Start Date
2021-01-14
Completion Date
2028-03-30
Last Updated
2025-03-25
Healthy Volunteers
No
Interventions
Catheterized Stenting
Catheterized stenting of vascular narrowings.
Locations (7)
Children's Hospital Los Angeles
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Boston Children's
Boston, Massachusetts, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Nationwide Children's
Columbus, Ohio, United States
Le Bonheur Children's
Memphis, Tennessee, United States
Seattle Children's Hospital
Seattle, Washington, United States