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NCT05086016 · ClinicalTrials.gov registry record · NA
Growth Trial: Study of the Renata Minima Stent
A NA study of Pulmonary Artery Stenosis and Coarctation of the Aorta, sponsored by Renata Medical.
- Active
- Registry status
- NA
- Development phase
- 42
- Enrollment target
- 7
- Study locations
NCT05086016: Active NA study of Pulmonary Artery Stenosis and Coarctation of the Aorta, sponsored by Renata Medical.
NCT05086016 is a NA study of Pulmonary Artery Stenosis and Coarctation of the Aorta that is active but no longer recruiting, run by Renata Medical. The registered enrollment target is 42 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05086016, a NA study of Pulmonary Artery Stenosis and Coarctation of the Aorta, is active but no longer recruiting, sponsored by Renata Medical.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
The primary efficacy endpoint will be assessed as the rate of clinical success, with the performance goal defined as a clinical success rate of greater than 77%. Clinical success is defined as: * Stenosis relief, defined by stent outer diameter ≥ 75% of the surrounding vessel immediately after deployment. * Freedom from open surgical intervention required to treat Minima Stent disfunction through 6 months. * Maintenance of stented vessel diameter ≥ 50% of post-implant diameter at 6 months; as
Conditions Studied
Interventions
- DEVICE Catheterized Stenting
Study Locations (7)
California
- Children's Hospital Los Angeles - Los Angeles
- Cedars-Sinai Medical Center - Los Angeles
Ohio
- Cincinnati Children's Hospital - Cincinnati
- Nationwide Children's - Columbus
Massachusetts
- Boston Children's - Boston
Tennessee
- Le Bonheur Children's - Memphis
Washington
- Seattle Children's Hospital - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2021-01-14 |
| Est. Completion | 2028-03-30 |
| Phase | NA |
What the registry record for NCT05086016 still lists
NCT05086016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Pulmonary Artery Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Catheterized Stenting is the first listed.
NCT05086016 lists 7 locations in 5 states (California, Ohio, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT05086016 about?
NCT05086016 is a clinical study titled "Growth Trial: Study of the Renata Minima Stent". 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 f...
What is the current status of trial NCT05086016?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 42 participants. The study started on 2021-01-14. Estimated completion is 2028-03-30.
What conditions does trial NCT05086016 study?
This clinical trial studies the following conditions: Pulmonary Artery Stenosis, Coarctation of the Aorta.
What interventions are being tested in trial NCT05086016?
The interventions under investigation include: Catheterized Stenting (DEVICE).
Who is sponsoring clinical trial NCT05086016?
This trial is sponsored by Renata Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05086016 being conducted?
This trial has 7 study locations across California, Massachusetts, Ohio, Tennessee, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05086016's enrollment target sits among peer trials
42 1436th of 2000 higher than 555 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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