RECRUITINGOBSERVATIONAL
Minima Stent System Post- Approval Study (PAS)
Post-Approval Study of the Renata Minima Stent in the Treatment of Vascular Stenoses in Neonates, Infants, and Small Children
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- The subject's legally authorized representative has been informed of the nature of the device treatment, agrees to its provisions, and has provided written willing to sign a consent form
- Indicated for treatment with the Minima Stent System per the IFU.
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
Treatments Being Tested
DEVICE
Minima Stent System
Minima Stent System is indicated for use in the treatment of native or acquired pulmonary artery stenoses or coarctation of the aorta in neonates, infants, and children at least 1.5kg in weight.
Locations (15)
Children's Hospital Los Angeles
Los Angeles, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Riley Hospital for Children at Indiana University Health
Indianapolis, Indiana, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Washington University
Saint Louis, Michigan, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Dell Children's Medical Center, The University of Texas at Austin
Austin, Texas, United States
Columbia Hospital at Medical City Dallas Hospital
Dallas, Texas, United States
UVA Health Children's Hospital
Charlottesville, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States