Clinical trial NCT03287024: BeGrow Study to Treat Pulmonary Artery (PA) Stenosis in Newborns and Infants
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Artery Stenosis
Lead sponsor: Bentley InnoMed GmbH
Sponsor class: INDUSTRY
First posted: 2017-09-19
Enrollment: 18
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Vessel enlargement in mm
timeFrame: after procedure and during follow ups up to 12 Months
measure: Incidence of serious adverse events device and procedure related
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medizinische Universität Wien, AKH Wien, Abteilung für Pädiatrische Kardiologie
city: Belgrade
country: Serbia
facility: University Children's Hospital, Center for Pediatrics - Department of Cardiology
city: Zürich
country: Switzerland
facility: Universitäts-Kinderspital Zürich
Study officials:
affiliation: Kinderspital Zürich, Pädiatrische Kardiologie
name: Oliver Kretschmar, Prof.Dr.med
role: PRINCIPAL_INVESTIGATOR
References:
citation: Quandt D, Knirsch W, Michel-Behnke I, Kitzmuller E, Obradovic M, Uhlemann F, Kretschmar O. First-in-man pulmonary artery stenting in children using the Bentley(R) BeGrow stent system for newborns and infants. Int J Cardiol. 2019 Feb 1;276:107-109. doi: 10.1016/j.ijcard.2018.11.029. Epub 2018 Nov 19.