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BeGrow Study to Treat Pulmonary Artery (PA) Stenosis in Newborns and Infants

NCT03287024 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-10-28

No results posted yet for this study

Summary

Objective of the study is to assess safety and performance of the BeGrow Stent System for newborns and infants in pulmonary artery stenosis.

Conditions

  • Pulmonary Artery Stenosis

Interventions

DEVICE

BeGrow Stent System

All enrolled subjects will undergo primary stenting of the target lesion by placement of the BeGrow Stent System

Sponsors & Collaborators

  • Bentley InnoMed GmbH

    lead INDUSTRY

Principal Investigators

  • Oliver Kretschmar, Prof.Dr.med · Kinderspital Zürich, Pädiatrische Kardiologie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-01
Primary Completion
2026-05-31
Completion
2027-05-31

Countries

  • Austria
  • Serbia
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03287024 on ClinicalTrials.gov