Minima Stent System Post- Approval Study (PAS)

Study Status: Recruiting

A minimum of 100 subjects will be enrolled. Follow-up will occur immediately after the initial implant procedure, at subsequent re-dilation procedures, annually, and at any additional standard of care follow-up visits (determined by the implanting physician) through 5 years post-implant. Data collected at each follow-up will be used in analysis. This study will monitor key data points related to the device and procedure.

Sex: ALL

Researchers look for people who fit a certain description, called eligibility criteria. Below are the inclusion and exclusion criteria for study participants:

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.

Exlusion 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

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Artery Stenosis, Aortic Coarctation

Intervention/Treatment

DEVICE : Minima Stent System

Sponsor

Renata Medical

Principal Investigator(s)

Arash Salavitabar, MD, PRINCIPAL_INVESTIGATOR, Nationwide Children's Hospital