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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03287024
• Date of registration: 07/09/2017
• Prospective Registration: Yes
• Primary sponsor: Bentley InnoMed GmbH
• Public title: BeGrow Study to Treat Pulmonary Artery (PA) Stenosis in Newborns and Infants
• Scientific 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
• Date of first enrolment: March 1, 2018
• Target sample size: 18
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03287024
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Austria, Serbia, Switzerland

Contacts

• Name: Oliver Kretschmar, Prof.Dr.med
• Affiliation: Kinderspital Zürich, Pädiatrische Kardiologie

Key inclusion & exclusion 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.



Age minimum: N/A
Age maximum: 24 Months
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Artery Stenosis

Intervention(s)

Device: BeGrow Stent System

Primary Outcome(s)

Vessel enlargement in mm [Time Frame: after procedure and during follow ups up to 12 Months]

Incidence of serious adverse events device and procedure related [Time Frame: 12 Months]

Secondary ID(s)

BNT002BeGrow

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

LS medcap GmbH