Growth Trial: Study of the Renata Minima Stent (NCT05086016) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Growth Trial: Study of the Renata Minima Stent
United States42 participantsStarted 2021-01-14
Plain-language summary
The objective of the clinical investigation is to access 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.
Who can participate
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria include:
* 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
Exclusion criteria include:
* 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 d…
What they're measuring
1
Number of Participants Demonstrating Clinical Success at 6 Months
Timeframe: Through 6-month follow-up Visit
2
Number of Participants With Freedom From Serious Adverse Events at 6 Months