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

Study Overview
=================
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.

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

Conditions
-----------------
Pulmonary Artery Stenosis

Intervention / Treatment
-----------------
* Device: BeGrow Stent System


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Maximum Age: 24 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BeGrow Stent System<br>All enrolled subjects will receive the BeGrow Stent System | Device: BeGrow Stent System<br>* All enrolled subjects will undergo primary stenting of the target lesion by placement of the BeGrow Stent System<br>|

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 |