Actively Recruiting
Post-Approval Study of the Renata Minima Stent for Treating Vascular Stenoses in Neonates, Infants, and Small Children
Led by Renata Medical ยท Updated on 2025-10-23
100
Participants Needed
15
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates the Renata Minima Stent System in neonates, infants, and small children with vascular narrowing conditions like pulmonary artery stenosis or aortic coarctation. It is a post-approval, multi-center, open-label study conducted in the United States to monitor the device's performance and collect real-world outcome data. Participants will receive treatment with the Renata Minima Stent System. The study involves one group of patients who have been implanted with this device. Follow-up visits will occur immediately after implantation, during any re-dilation procedures, annually, and at other standard care visits as determined by the implanting physician. The study will track key data related to the device and the procedure over a period of up to 5 years post-implant. During the study, researchers will collect information at each follow-up to analyze the device's success rate at implantation and monitor for serious adverse events related to the procedure or device. They will also track outcomes like stent re-dilation success, pressure gradients, stent migration, embolization, and any need for unplanned stent removal. Participants will be observed and assessed over several years to gather comprehensive safety and performance data.
CONDITIONS
Brief Title
Minima Stent System Post- Approval Study (PAS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The legally authorized representative has been informed about the device treatment and has provided written consent
- The patient is indicated for treatment with the Minima Stent System according to its instructions for use
You will not qualify if you...
- Active bloodstream infection requiring antibiotic therapy within 3 days before stent implantation
- History of or active endocarditis with antibiotic treatment within 180 days before stent implantation
- Aortic or pulmonary artery aneurysm at the treatment site
- Body weight less than 1.5 kg
- Lesion location unsuitable for safe stent placement as judged by investigator
- Target vessels outside the size range of the Minima System balloon
- Known genetic syndromes associated with blood vessel problems such as Williams or Loeys-Dietz syndrome
- Need for stent implantation in more than one vessel during the procedure
- Participation in another investigational drug or device study
- Major or progressive non-cardiac disease with life expectancy under six months
- Known allergy to aspirin or heparin not manageable with other medications
- Known allergy to cobalt-chromium or contrast media not manageable with premedication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive the Minima Stent System implant procedure for treating vascular stenoses.
1 implant procedure visit (in-person)
Duration - Up to 5 years
Participants are monitored immediately after the implant procedure, at any re-dilation procedures, annually, and during additional standard of care visits determined by the implanting physician through 5 years post-implant.
Visits immediately post-implant, during re-dilation procedures, annually, and at additional standard of care follow-up visits
Trial Site Locations
Total: 15 locations
1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Actively Recruiting
4
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
Actively Recruiting
5
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
6
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States, 46202
Actively Recruiting
7
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
8
Washington University
Saint Louis, Michigan, United States, 63130
Actively Recruiting
9
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
10
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
11
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
12
Dell Children's Medical Center, The University of Texas at Austin
Austin, Texas, United States, 78723
Actively Recruiting
13
Columbia Hospital at Medical City Dallas Hospital
Dallas, Texas, United States, 75230
Actively Recruiting
14
UVA Health Children's Hospital
Charlottesville, Virginia, United States, 22903
Actively Recruiting
15
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
R
Renata Medical Clinical & Regulatory Affairs
R
Renata Medical Corporate
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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