Prospective, Multicenter, Single-arm Study to Assess the Safety and Performance of the BeGrow Stent System in Newborns and Infants to Treat Pulmonary Artery Stenosis
Sponsor study identifier
interventional
18
3 countries
3
Study Start
March 1, 2018
Actual (reported)Primary Completion
May 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Objective of the study is to assess safety and performance of the BeGrow Stent System for newborns and infants in pulmonary artery stenosis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 7, 2017
Actual (reported)September 19, 2017
Actual (reported)March 1, 2018
Actual (reported)May 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Vessel enlargement in mm
Vessel enlargement will be measured in mm, directly before and after stent implantation by angiography
after procedure and during follow ups up to 12 Months
Incidence of serious adverse events device and procedure related
Incidence of SAE
12 Months
All enrolled subjects will receive the BeGrow Stent System
All enrolled subjects will undergo primary stenting of the target lesion by placement of the BeGrow Stent System
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Medizinische Universität Wien, AKH Wien, Abteilung für Pädiatrische Kardiologie
Vienna, 1090, Austria
University Children's Hospital, Center for Pediatrics - Department of Cardiology
Belgrade, 11000, Serbia
Universitäts-Kinderspital Zürich
Zurich, 8032, Switzerland
Quandt D, Knirsch W, Michel-Behnke I, Kitzmuller E, Obradovic M, Uhlemann F, Kretschmar O. First-in-man pulmonary artery stenting in children using the Bentley(R) BeGrow stent system for newborns and infants. Int J Cardiol. 2019 Feb 1;276:107-109. doi: 10.1016/j.ijcard.2018.11.029. Epub 2018 Nov 19.
Oliver Kretschmar, Prof.Dr.med
Kinderspital Zürich, Pädiatrische Kardiologie
18 participants (actual enrollment reported by the registry).
First Submitted
September 7, 2017
First Posted
September 19, 2017
Post-Approval Study of PALMAZ MULLINS XD™ in Treating Pulmonary Artery Stenosis
Contact the study team to confirm eligibility.
Study Start
March 1, 2018
Actual (reported)Primary Completion
May 31, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 28, 2024
Record last verified: 2024-10
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Source: ClinicalTrials.gov.
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