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

NCT03287024 | Active Not Recruiting DMC

• 1 other identifier: BNT002BeGrow
• Study Type: interventional
• Target: 18
• Locations: 3 countries
• Sites: 3

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.

Conditions

Pulmonary Artery Stenosis

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

BeGrow Stent System

EXPERIMENTAL

All enrolled subjects will receive the BeGrow Stent System

Device: BeGrow Stent System

Interventions

BeGrow Stent System DEVICE

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

BeGrow Stent System

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bentley InnoMed GmbH: lead

Study Sites (3)

Medizinische Universität Wien, AKH Wien, Abteilung für Pädiatrische Kardiologie

Vienna, 1090, Austria

Location

University Children's Hospital, Center for Pediatrics - Department of Cardiology

Belgrade, 11000, Serbia

Location

Universitäts-Kinderspital Zürich

Zurich, 8032, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 30477928 DERIVED

MeSH Terms

Conditions

Stenosis, Pulmonary Artery

Condition Hierarchy (Ancestors)

Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Oliver Kretschmar, Prof.Dr.med

  Kinderspital Zürich, Pädiatrische Kardiologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-centre, explorative single-arm study This open-label, non-randomized multi-centre study uses an "umbrella protocol" (Part A and Part B) designed to collect data for performance and safety as well as long-term safety data from pulmonary artery stenosis patients who are treated with the BeGrow stent system to treat the stenosis Part A: Safety and Performance (Implantation and Re-dilatation) Part B: Safety on Long-Term Follow-up

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 19, 2017
• Study Start: March 1, 2018
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2027
• Last Updated: October 28, 2024

Record last verified: 2024-10

Locations

AU (1); SE (1); CH (1)