Objective of the study is to assess safety and performance of the BeGrow Stent System for newborns and infants in pulmonary artery stenosis.
The Bentley InnoMed "BeGrow Stent System for Newborns and Infants" is a stent delivery system indicated for intraluminal placement in the pulmonary arteries of newborns and infants for the treatment of Pulmonary Artery Stenosis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
All enrolled subjects will undergo primary stenting of the target lesion by placement of the BeGrow Stent System
Medizinische Universität Wien, AKH Wien, Abteilung für Pädiatrische Kardiologie
Vienna, Austria
University Children's Hospital, Center for Pediatrics - Department of Cardiology
Belgrade, Serbia
Universitäts-Kinderspital Zürich
Zurich, Switzerland
Vessel enlargement in mm
Vessel enlargement will be measured in mm, directly before and after stent implantation by angiography
Time frame: after procedure and during follow ups up to 12 Months
Incidence of serious adverse events device and procedure related
Incidence of SAE
Time frame: 12 Months
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