Clinical trials: Pulmonary Artery Stenosis
Pulmonary Artery Stenosis
A Clinical Trial to Evaluate the Safety and Efficacy of IBS Angel in Patients With Pulmonary Artery Stenosis
This is a prospective, multi-center, single-arm clinical trial to evaluate the safety and efficacy of Iron Bioresorbable Scaffold System (IBS Angel) in patients with pulmonary artery stenosis.
- Trial name
- IRIS (NCT04973540)
- Testing
- Iron Bioresorbable Scaffold System (IBS Angel)
- Where
- 10 sites in China
- Volunteers
- 82 people
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
Pulmonary Artery Stenosis, Aortic Coarctation
Minima Stent System Post- Approval Study (PAS)
This Post-Approval Study is a single arm, prospective, multi-center, open-label study of patients treated with the Renata Minima Stent System in the United States.
- Trial name
- NCT06828770
- Testing
- Minima Stent System
- Where
- 15 sites in United States
- Volunteers
- 100 people
- Sponsor
- Renata Medical
Aortic Coarctation, Pulmonary Artery Stenosis
First-in-human Clinical Trial to Assess Safety and Efficacy of the CardiaZn Bioresorbable Stent in Children With Pulmonary Artery Stenosis and Aortic Coarctation
This study evaluates the safety and effectiveness of the CardiaZn stent, a novel bioresorbable stent designed specifically for infants and children with congenital cardiovascular conditions.
- Trial name
- Pediasorb (NCT07628101)
- Testing
- CardiaZn Bioresorbable Stent
- Volunteers
- 45 people
- Sponsor
- PediaStent LLC
Coarctation of the Aorta, Pulmonary Artery Stenosis
Growth Trial: Study of the Renata Minima Stent
The objective of the clinical investigation is to access clinical safety and effectiveness of the Minima Stent in neonates, infants, and young children requiring intervention for common congenital vascular stenosis (i.e.…
- Trial name
- NCT05086016
- Testing
- Catheterized Stenting
- Where
- 7 sites in United States
- Volunteers
- 42 people
- Sponsor
- Renata Medical
Pulmonary Artery Stenosis
Post-Approval Study of PALMAZ MULLINS XD™ in Treating Pulmonary Artery Stenosis
The purpose of the clinical investigation is to characterize clinical outcomes and to assess the real-world use of the commercial PALMAZ MULLINS XD™ Pulmonary Stent.
- Trial name
- REALPASS (NCT07122518)
- Testing
- PALMAZ MULLINS XD™ Pulmonary Stent
- Where
- 8 sites in United States
- Volunteers
- 35 people
- Sponsor
- Cordis US Corp.
Pulmonary Artery Stenosis
BeGrow Study to Treat Pulmonary Artery (PA) Stenosis in Newborns and Infants
Objective of the study is to assess safety and performance of the BeGrow Stent System for newborns and infants in pulmonary artery stenosis.
- Trial name
- NCT03287024
- Testing
- BeGrow Stent System
- Where
- 3 sites in Austria, Serbia and 1 more
- Volunteers
- 18 people
- Sponsor
- Bentley InnoMed GmbH
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT)…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT02744677
- Testing
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
- Where
- 27 sites in United States
- Volunteers
- 108 people
- Sponsor
- Edwards Lifesciences