Clinical trials: Arteriosus
Patent Ductus Arteriosus
Amplatzer Piccolo Occluder Japan Post-marketing Database Surveillance
The purpose of this post-marketing clinical use database surveillance is to observe the frequency, type, and degree of adverse device effects and adverse events in order to assure the safety of the medical device, and to collect…
- Trial name
- NCT04371081
- Testing
- Amplatzer Piccolo Occluder
- Where
- Japan
- Volunteers
- 70 people
- Sponsor
- Abbott Medical Devices
Patent Ductus Arteriosus
AMPLATZER Duct Occluder II Additional Sizes
The ADO II AS Study is a single arm, prospective, multicenter, nonrandomized clinical investigation to characterize the safety and effectiveness of the ADO II AS device in patients with a patent ductus arteriosus (PDA).
- Trial name
- ADO II AS (NCT03055858)
- Testing
- ADO II AS (PDA closure)
- Where
- 9 sites in United States
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Patent Foramen Ovale, Atrial Septal Defect
Lifetech CeraFlex™ Post-Market Surveillance Study
The purpose of this multi-center, non-interventional, prospective, post-market clinical study is to collect real world data on patient outcomes and evaluate the procedural success and performance of the Lifetech CeraFlex™…
- Conditions
- Patent Foramen Ovale, Atrial Septal Defect, Patent Ductus Arteriosus
- Trial name
- NCT02621528
- Testing
- CeraFlex
- Where
- 7 sites in France, Germany and 3 more
- Volunteers
- 120 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Ductus Arteriosus, Patent
NIT-OCCLUD PDA Phase II Sentinel Trial
The purpose of this study is to evaluate the safety and efficacy of the Nit-Occlud -PDA Occlusion System for transcatheter closure of PDA with minimum angiographic diameter less than 4 mm, and to compare one year safety and…
- Trial name
- NCT00828334
- Testing
- Transcatheter PDA Coil
- Where
- 15 sites in United States
- Volunteers
- 357 people
- Sponsor
- PFM Medical, Inc
Patent Ductus Arteriosus
Safety and Efficacy Study of Ibuprofen l-Lysine Solution in Premature Infants for Treatment of PDA
The purpose of this study is to determine the safety and effectiveness of ibuprofen l-lysine iv in premature infants in the early treatment of Patent Ductus Arteriosus.
- Trial name
- NCT00440804
- Testing
- ibuprofen l-lysine iv solution (NeoProfen (R) )
- Sponsor
- Farmacon
Patent Ductus Arteriosus
Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus
The objective of the study is to investigate the safety, efficacy and clinical utility of the Occlutech PDA device for closure of patent ductus arteriosus of all types.
- Trial name
- NCT01479218
- Testing
- Occlutech PDA occluder
- Where
- 2 sites in Malaysia, Vietnam
- Volunteers
- 50 people
- Sponsor
- Occlutech International AB
PTA (Percutaneous Transluminal Angioplasty ), Femoropopliteal Artery Disease
Clinical Outcomes of GENOSS PCB for Femoropopliteal Artery Disease
The GENOSS PCB study aims to evaluate the safety and efficacy of a Paclitaxel-coated PTA Balloon Catheter(GENOSS® PCB) in patients with the femoropopliteal artery disease.
- Trial name
- GENOSS PCB (NCT07399080)
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Genoss Co., Ltd.
Ductus Arteriosus, Patent
Paracetamol in Patent Ductus Arteriosus
The purpose of the study is to assess the efficacy and safety of paracetamol in comparison to ibuprofen in the treatment of patent ductus arteriosus (PDA) in preterm infants.
- Trial name
- NCT02422966
- Testing
- Paracetamol, Ibuprofen
- Where
- 5 sites in Italy
- Volunteers
- 110 people
- Sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
Patent Ductus Arteriosus
AMPLATZER Duct Occluder II Clinical Study
The objective of this study is to investigate the safety and effectiveness of the ADO II in patients with a PDA.
- Trial name
- ADO II (NCT00713700)
- Testing
- AMPLATZER Duct Occluder II
- Where
- 25 sites in United States
- Volunteers
- 192 people
- Sponsor
- Abbott Medical Devices
Patent Ductus Arteriosus (PDA)
PREEMIE: Study for Treatment of PDA in Premature Infants
This multicenter, single arm, prospective, non-randomized study is designed to evaluate the safety and effectiveness of The Bloom Micro Occluder System for the treatment of patent ductus arteriosus (PDA) in pre-mature infants…
- Trial name
- PREEMIE (NCT06587282)
- Testing
- Bloom Micro Occluder System
- Where
- 9 sites in United States
- Volunteers
- 55 people
- Sponsor
- Merit Medical Systems, Inc.
PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease
Safety and Effectiveness of GENOSS PCB in Patients With Long Femoropopliteal Lesion
The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB in patients with long femoropopliteal lesions who underwent percutaneous transluminal angioplasty using GENOSS PCB.
- Conditions
- PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease, Long Femoropopliteal Artery Disease
- Trial name
- NCT07425171
- Where
- South Korea
- Volunteers
- 300 people
- Sponsor
- Genoss Co., Ltd.
Patent Ductus Arteriosus (PDA)
Nit-Occlud PDA Post-Approval Study
The Nit-Occlud PDA Post-Approval Study is designed to continue to evaluate the safety and effectiveness of the device in the post-approval phase.
- Trial name
- NCT02100683
- Testing
- PDA Coil
- Where
- 11 sites in United States
- Volunteers
- 184 people
- Sponsor
- PFM Medical, Inc
Patent, Ductus
Emergency/Compassionate Use - AMPLATZER Duct Occluder
Emergency/compassionate use for the AMPLATZER Duct Occluder
- Conditions
- Patent, Ductus, Arteriosus
- Trial name
- NCT00583583
- Testing
- Device closure with the AMPLATZER Duct Occluder
- Sponsor
- Abbott Medical Devices
Patent Ductus Arteriosus, Duct-dependent Cyanotic Congenital Heart Disease
Feasibility, Efficacy and Safety of IBS ® for Implantaiton in the PDA in Duct-dependent Cyanotic CHD
This is a pilot study on feasibility, efficacy and safety of IBS ® for implantation in the PDA in duct-dependent cyanotic CHD, and its objective is to investigate the feasibility, safety and efficacy of iron resorbable stent…
- Trial name
- NCT04291222
- Testing
- Iron biocorrodable coronary scaffold system
- Where
- Malaysia
- Volunteers
- 10 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
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
Congenital Heart Disease, Congenital Heart Disease (CHD)
Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study
Starlight Cardiovascular, Inc. is sponsoring a prospective, multi-center, study to evaluate safety and effectiveness of the Lifeline Ductus Arteriosus Stent System.
- Trial name
- NCT07114718
- Testing
- Ductus Arteriosus Stent
- Where
- 10 sites in United States
- Volunteers
- 45 people
- Sponsor
- Starlight Cardiovascular Inc
Patent Ductus Arteriosus
Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects
This retrospective and prospective, multicenter, international post marketing follow up study evaluates the safety and efficacy of the Occlutech® PDA Occluder, delivered using the Occlutech Occlusions Pusher (OOP), in subjects…
- Trial name
- NCT05264753
- Testing
- Occlutech® PDA Occluder
- Where
- 15 sites in Canada, France and 7 more
- Volunteers
- 255 people
- Sponsor
- Occlutech International AB
PTA (Percutaneous Transluminal Angioplasty), Femoropopliteal Artery Disease
One-Year Results of GENOSS PCB Real-World Study in Femoropopliteal Artery Disease
The purpose of this study is to evaluate the long-term safety and efficacy of GENOSS PCB by enrolling and tracking patients who underwent percutaneous transluminal angioplasty using GENOSS PCB in patients with femoropopliteal…
- Trial name
- NCT07431437
- Where
- South Korea
- Volunteers
- 300 people
- Sponsor
- Genoss Co., Ltd.
Intermittent Claudication, Atherosclerotic Disease
Edwards Lifesciences Self-Expanding Stent Peripheral Vascular Disease Study
The main objective of this study is to assess the safety and effectiveness of the Edwards Lifesciences LifeStent nitinol self expandable stent device and its delivery system in the treatment of occlusive superficial femoral…
- Conditions
- Intermittent Claudication, Atherosclerotic Disease, Arterial Occlusive Disease
- Trial name
- RESILIENT (NCT00673985)
- Testing
- Percutaneous Transluminal Angioplasty, LifeStent NT™ Self-Expanding Peripheral Stent
- Volunteers
- 246 people
- Sponsor
- C. R. Bard
Patent Ductus Arteriosus (PDA)
Closure Of Patent Ductus Arteriosus With the AMPLATZER Duct Occluder the AMPLATZER® Duct Occluder
AGA-004 - The objective of the study is to determine safety, effectiveness and clinical utility of the AMPLATZER Duct Occluder in patients with patent ductus arteriosus.
- Trial name
- NCT00583596
- Testing
- Device closure with AMPLATZER Duct Occluder, Objective Performance Criteria
- Where
- 24 sites in United States
- Volunteers
- 436 people
- Sponsor
- Abbott Medical Devices