RenataMedical_PTC-0009 (Minima Stent)

What is the Purpose of this Study?

The objective of the clinical investigation is to access device performance and the initial clinical safety and effectiveness of the Minima Stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis (i.e., coarctation of the aorta and/or pulmonary artery stenosis) who are indicated for treatment.


Eligibility

  • * 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
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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Multicenter Early Feasibility Trial of Neonatal, Infant, and Young Child Vascular Stenoses Studying the Renata Minima Stent

Study Details
Disease Type/Condition

Other

Principal Investigator

Markush, Dor

Age Group

Children

Phase

N/A

IRB Number

STUDY00001825

ClinicalTrials.gov ID

NCT05086016

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Email
clinicaltrials@cshs.org
Study Detail
Disease Type/Condition

Other

Principal Investigator

Markush, Dor

Age Group

Children

Phase

N/A

IRB Number

PTC-0009

ClinicalTrials.gov ID

NCT05086016

Key Eligibility
ClinicalTrials.gov

Contact
Email
clinicaltrials@cshs.org