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

Pulmonary Artery Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03287024
• Other study ID #: BNT002BeGrow
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: May 31, 2024

Study information

• Verified date: July 2020
• Source: Bentley InnoMed GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Pulmonary Artery Stenosis

Intervention

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

Locations

Country	Name	City	State
Austria	Medizinische Universität Wien, AKH Wien, Abteilung für Pädiatrische Kardiologie	Vienna
Serbia	University Children's Hospital, Center for Pediatrics - Department of Cardiology	Belgrade
Switzerland	Universitäts-Kinderspital Zürich	Zürich

Sponsors (2)

Lead Sponsor	Collaborator
Bentley InnoMed GmbH	LS medcap GmbH

Countries where clinical trial is conducted

Austria,  Serbia,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of serious adverse events device and procedure related	Incidence of SAE	12 Months