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

NCT ID: NCT03287024

Last Updated: 2024-10-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2027-05-31

Brief Summary

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

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.

Conditions

Pulmonary Artery Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BeGrow Stent System

All enrolled subjects will receive the BeGrow Stent System

Group Type: EXPERIMENTAL

BeGrow Stent System

Intervention Type: DEVICE

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

Interventions

BeGrow Stent System

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

Intervention Type: DEVICE

Eligibility Criteria

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 informed consent (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

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

• Shunt stenosis
• Valvular and subvalvular pulmonary stenosis
• Patients with known hypersensitivity 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.

• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bentley InnoMed GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Oliver Kretschmar, Prof.Dr.med

Role: PRINCIPAL_INVESTIGATOR

Kinderspital Zürich, Pädiatrische Kardiologie

Locations

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

Countries

Austria; Serbia; Switzerland

References

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.

Reference Type: DERIVED

PMID: 30477928 (View on PubMed)

Other Identifiers

BNT002BeGrow

Identifier Type: -

Identifier Source: org_study_id