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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Pulmonary Artery Stenosis
• Intervention / Treatment: Device: BeGrow Stent System

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medizinische Universität Wien, AKH Wien, Abteilung für Pädiatrische Kardiologie
• Serbia
  • Belgrade, Serbia, 11000
    • University Children's Hospital, Center for Pediatrics - Department of Cardiology
• Switzerland
  • Zürich, Switzerland, 8032
    • Universitäts-Kinderspital Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BeGrow Stent System; All enrolled subjects will receive the BeGrow Stent System	Device: BeGrow Stent System; All enrolled subjects will undergo primary stenting of the target lesion by placement of the BeGrow Stent System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Bentley InnoMed GmbH
• Collaborators: LS medcap GmbH
• Investigators: Principal Investigator: Oliver Kretschmar, Prof.Dr.med, Kinderspital Zürich, Pädiatrische Kardiologie

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: September 7, 2017
• First Submitted That Met QC Criteria: September 15, 2017
• First Posted (Actual): September 19, 2017

Study Record Updates

• Last Update Posted (Actual): October 28, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Arterial Occlusive Diseases; Stenosis, Pulmonary Artery; Constriction, Pathologic
• Other Study ID Numbers: BNT002BeGrow

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No