Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Renata Medical
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
The subject's legally authorized representative has been informed of the nature of the clinical investigation, agrees to its provisions, and has provided written informed consent
Requiring treatment\* of:
* native, acquired, or recurrent aortic coarctation, or
* native, acquired, or recurrent pulmonary artery stenosis \*As defined by the patient's medical team
Patency of at least one femoral vein, femoral artery, jugular vein or both carotid arteries able to accommodate the delivery system
Adjacent vessel to stenosis measuring \> or equal to 4 mm
You may not be if
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 pre-medicated
Clareo Health | Growth Trial: Study of the Renata Minima Stent
