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

Primary Purpose

Pulmonary Artery Stenosis

Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
BeGrow Stent System
Sponsored by
Bentley InnoMed GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Artery Stenosis

Eligibility Criteria

undefined - 24 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medizinische Universität Wien, AKH Wien, Abteilung für Pädiatrische Kardiologie
  • University Children's Hospital, Center for Pediatrics - Department of Cardiology
  • Universitäts-Kinderspital Zürich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BeGrow Stent System

Arm Description

All enrolled subjects will receive the BeGrow Stent System

Outcomes

Primary Outcome Measures

Vessel enlargement in mm
Vessel enlargement will be measured in mm, directly before and after stent implantation by angiography
Incidence of serious adverse events device and procedure related
Incidence of SAE

Secondary Outcome Measures

Full Information

First Posted
September 7, 2017
Last Updated
July 27, 2020
Sponsor
Bentley InnoMed GmbH
Collaborators
LS medcap GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03287024
Brief Title
BeGrow Study to Treat Pulmonary Artery (PA) Stenosis in Newborns and Infants
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bentley InnoMed GmbH
Collaborators
LS medcap GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Artery Stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BeGrow Stent System
Arm Type
Experimental
Arm Description
All enrolled subjects will receive the BeGrow Stent System
Intervention Type
Device
Intervention Name(s)
BeGrow Stent System
Intervention Description
All enrolled subjects will undergo primary stenting of the target lesion by placement of the BeGrow Stent System
Primary Outcome Measure Information:
Title
Vessel enlargement in mm
Description
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
Title
Incidence of serious adverse events device and procedure related
Description
Incidence of SAE
Time Frame
12 Months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver Kretschmar, Prof.Dr.med
Organizational Affiliation
Kinderspital Zürich, Pädiatrische Kardiologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universität Wien, AKH Wien, Abteilung für Pädiatrische Kardiologie
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
University Children's Hospital, Center for Pediatrics - Department of Cardiology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Universitäts-Kinderspital Zürich
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
30477928
Citation
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.
Results Reference
derived

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

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