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

Bentley InnoMed

Status: Active, not recruiting

Conditions: Pulmonary Artery Stenosis

Treatments: Device: BeGrow Stent System

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03287024

BNT002BeGrow

Details and patient eligibility

About

Objective of the study is to assess safety and performance of the BeGrow Stent System for newborns and infants in pulmonary artery stenosis.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: Under 24 months old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

BeGrow Stent System

Experimental group

Description:

All enrolled subjects will receive the BeGrow Stent System

Treatment:

Device: BeGrow Stent System