Trials / Active Not Recruiting
Active Not RecruitingNCT03287024
BeGrow Study to Treat Pulmonary Artery (PA) Stenosis in Newborns and Infants
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
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Bentley InnoMed GmbH · Industry
- Sex
- All
- Age
- 24 Months
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | BeGrow Stent System | All enrolled subjects will undergo primary stenting of the target lesion by placement of the BeGrow Stent System |
Timeline
- Start date
- 2018-03-01
- Primary completion
- 2026-05-31
- Completion
- 2027-05-31
- First posted
- 2017-09-19
- Last updated
- 2024-10-28
Locations
3 sites across 3 countries: Austria, Serbia, Switzerland
Source: ClinicalTrials.gov record NCT03287024. Inclusion in this directory is not an endorsement.