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

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.

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.