Actively Recruiting
Minima Stent System Post- Approval Study (PAS)
Led by Renata Medical · Updated on 2025-10-23
100
Participants Needed
15
Research Sites
340 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This Post-Approval Study is a single arm, prospective, multi-center, open-label study of patients treated with the Renata Minima Stent System in the United States. The objective of the study is to continue the assessment of device performance and capture outcome data on use of the device in real-world use.
CONDITIONS
Official Title
Minima Stent System Post- Approval Study (PAS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The subject's legally authorized representative has been informed of the nature of the device treatment, agrees to its provisions, and has provided written informed consent
- Indicated for treatment with the Minima Stent System per the IFU
You will not qualify if you...
- Active bloodstream infection requiring antibiotic therapy within 3 days prior to stent implantation
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
R
Renata Medical Corporate
CONTACT
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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