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Active, not recruitingNCT03287024Updated Oct 28, 2024

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

An interventional study of BeGrow Stent System in Pulmonary Artery Stenosis, sponsored by Bentley InnoMed GmbH. Active, not recruiting at 3 sites in 3 countries. Open to participants aged Up to 24 Months. Per ClinicalTrials.gov, last updated 2024-10-28.

Sponsored by Bentley InnoMed GmbH · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 5 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Not applicable
Ages
Up to 24 Months
Sex
All
01

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.

Read the detailed description

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.

02

Conditions studied

  • Pulmonary Artery Stenosis
03

In context

Lead sponsor

Bentley InnoMed GmbH is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 24 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Single lesion(s) which can be treated with a 6 mm BeGrow stent (only one stent per lesion allowed).

  • Pulmonary artery stenosis - patient must at least have one of the following diseases:

    • Haemodynamically relevant proximal or distal branch pulmonary artery stenosis with a reduction of the vessel diameter when the vessel/patient is large enough to accommodate a stent,
    • Haemodynamically relevant stenosis of the main pulmonary artery segment that results in elevation of the Right Ventricle (RV) pressure, provided that the stent definitely will not compromise a functioning pulmonary valve and will not impinge on the pulmonary artery bifurcation,
    • Any degree of stenosis in patients with single ventricle circulation
    • Critically ill postoperative cardiac patients when it has been determined that branch pulmonary artery stenosis is resulting in a definite haemodynamic compromise in a patient/vessel of any size, particularly if balloon dilatation is unsuccessful
  • Signed written (by parents/legal guardians)
  • Lesion can be accessed with a guide wire or balloon catheter
  • Age ≤ 24 months and weight ≥ 2 kg
  • Adequate stent length available

Exclusion criteria

Exclusion Criteria:

  • The following lesions are excluded from treatment with BeGrow stent:

    • Shunt stenosis
    • Valvular and subvalvular pulmonary stenosis
  • Patients with known to the stent material (L605 cobalt-chromium).
  • Patients with clinical or biological signs of infection.
  • Patients with active endocarditis.
  • Patients with known allergy to acetylsalicylic acid, other antiplatelet agents or heparin.
  • Presence of other previously implanted stents in the same lesion or in close proximity to stent (direct stent-stent contact).
  • Patients with known coagulation disorder.
  • Patients where direct stent-stent contact or overlapping cannot be avoided.
  • Patients where contact to the vessel wall over the entire stent length cannot be ensured after dilatation (especially in short and thick lesions).
  • Patients where the BeGrow stent could protrude freely into adjacent vessels after expansion/dilatation, including the pulmonary arterial bifurcation.
  • Implantation of the BeGrow stent in the pulmonary arterial bifurcation.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Experimental
    BeGrow Stent System

    All enrolled subjects will receive the BeGrow Stent System

    Device: BeGrow Stent System

Interventions

  • DeviceBeGrow Stent System

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

06

What researchers measure

Primary outcomes

  1. 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

  2. Incidence of serious adverse events device and procedure related

    Incidence of SAE

    Time frame: 12 Months

07

Study locations

3 sites
  • 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
    Zürich, 8032, Switzerland
08

References and documents

Publications

  • 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. PubMed 30477928 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2018 (actual). Primary completion is estimated for May 2026, 98 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 7, 2017
First posted
Sep 19, 2017
StartActual
Mar 1, 2018
Primary completionEst.
May 31, 2026
CompletionEst.
May 31, 2027
Last update
Oct 28, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03287024
Lead sponsor
Bentley InnoMed GmbH
Responsible party
Sponsor
First posted
Sep 19, 2017
Start date
Mar 1, 2018
Primary completion
May 31, 2026 (estimated)
Completion
May 31, 2027 (estimated)
Last update
Oct 28, 2024

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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Other studies in this condition

Stenosis, Pulmonary Artery

Other studies from this sponsor

Bentley InnoMed GmbH

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