Pulmonary Artery StenosisNCT03287024
BeGrow Study to Treat Pulmonary Artery (PA) Stenosis in Newborns and Infants
A study testing BeGrow Stent System in people with Pulmonary Artery Stenosis, run by Bentley InnoMed GmbH at 3 sites in 3 countries.
Trial summary
Objective of the study is to assess safety and performance of the BeGrow Stent System for newborns and infants in pulmonary artery stenosis. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Pulmonary Artery Stenosis
- What is being tested?
- BeGrow Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Mar 2018to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Show all 13Show fewer
- 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 locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Austria1 site
Medizinische Universität Wien, AKH Wien, Abteilung für Pädiatrische Kardiologie
Vienna, 1090
Serbia1 site
University Children's Hospital, Center for Pediatrics - Department of Cardiology
Belgrade, 11000
About this study
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
Objective of the study is to assess safety and performance of the BeGrow Stent System for newborns and infants in pulmonary artery stenosis.
Read the 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.
- Conditions
- Pulmonary Artery Stenosis
- Being tested
- BeGrow Stent System
- Medical subject headings
- Stenosis, Pulmonary Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeGrow Stent SystemDevice
All enrolled subjects will undergo primary stenting of the target lesion by placement of the BeGrow Stent System
| Study group | Role | What they receive |
|---|---|---|
| BeGrow Stent System | Experimental | All enrolled subjects will receive the BeGrow Stent System Receives: Device: BeGrow Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vessel enlargement in mm
Vessel enlargement will be measured in mm, directly before and after stent implantation by angiography
Measured: after procedure and during follow ups up to 12 Months
Incidence of serious adverse events device and procedure related
Incidence of SAE
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start1 Mar 2018
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bentley InnoMed GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oliver Kretschmar, Prof.Dr.med, Principal investigator, Kinderspital Zürich, Pädiatrische Kardiologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287024
- Sponsor's protocol ID
- BNT002BeGrow
- Status last verified
- Oct 2024
- First submitted
- 7 Sep 2017
- Last updated
- 28 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30477928
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03287024
- Acronym / sponsor ID
- BNT002BeGrow
- Conditions
- Pulmonary Artery Stenosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Bentley InnoMed GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 19 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| BeGrow Stent System | Experimental | Device: BeGrow Stent SystemAll enrolled subjects will receive the BeGrow Stent System |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (13 listed)
- The following lesions are excluded from treatment with BeGrow stent:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BeGrow Stent SystemAll enrolled subjects will undergo primary stenting of the target lesion by placement of the BeGrow Stent System | Device | BeGrow Stent System |
Primary outcome
Vessel enlargement in mm
Time frame: after procedure and during follow ups up to 12 Months
Vessel enlargement will be measured in mm, directly before and after stent implantation by angiography
Incidence of serious adverse events device and procedure related
Time frame: 12 Months
Incidence of SAE
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2024.
- Derived from this study: PubMed 30477928Quandt 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.
Related trials for Pulmonary Artery Stenosis
Not yet recruitingObservational study
Vascular Health and Function in Cystic Fibrosis
Cystic Fibrosis, Endothelial Dysfunction
Active, not recruitingObservational study
Expanded Studies on the SCAPIS Stockholm Reexamination Cohort
Coronary Artery Disease, Arterial Stiffness, Blood Pressure
RecruitingObservational study
Post-Approval Study of PALMAZ MULLINS XD™ in Treating Pulmonary Artery Stenosis
Pulmonary Artery Stenosis
Recruiting
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
Not yet recruiting
First-in-human Clinical Trial to Assess Safety and Efficacy of the CardiaZn Bioresorbable Stent in Children With Pulmonary Artery Stenosis and Aortic Coarctation
Aortic Coarctation, Pulmonary Artery Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Kretschmar, Prof.Dr.med principal investigator
Kinderspital Zürich, Pädiatrische Kardiologie
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BeGrow Stent System in people with Pulmonary Artery Stenosis, run by Bentley InnoMed GmbH at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Serbia, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vessel enlargement in mm (time frame: after procedure and during follow ups up to 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03287024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2024.