Trials / Active Not Recruiting
Active Not RecruitingNCT05086016
Growth Trial: Study of the Renata Minima Stent
GROWTH: A Multicenter Pivotal Study of Neonatal, Infant, and Young Child Vascular Stenoses Studying the Renata Minima Stent
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 42 (actual)
- Sponsor
- Renata Medical · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Catheterized Stenting | Catheterized stenting of vascular narrowings. |
Timeline
- Start date
- 2021-01-14
- Primary completion
- 2024-02-26
- Completion
- 2028-03-30
- First posted
- 2021-10-20
- Last updated
- 2025-03-25
- Results posted
- 2025-03-25
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05086016. Inclusion in this directory is not an endorsement.