Objective of the study is to assess safety and performance of the BeGrow Stent System for newborns and infants in pulmonary artery stenosis.
Who can participate
Age range24 Months
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 infec…
What they're measuring
1
Vessel enlargement in mm
Timeframe: after procedure and during follow ups up to 12 Months
2
Incidence of serious adverse events device and procedure related