Clinical trials: Intervention
Acute Coronary Syndrome, Percutaneous Coronary Intervention
Efficacy and Safety of GENOSS® SES in Patients With Acute Coronary Syndrome (GENOSS ACS)
The objective of this study is to evaluate the efficacy and safety of the GENOSS SES in patients with acute coronary syndrome (ACS) in real-world pratice.
- Trial name
- GENOSS ACS (NCT06075368)
- Testing
- GENOSS Sirolimus Eluting Coronary Stent System
- Where
- South Korea
- Volunteers
- 757 people
- Sponsor
- Genoss Co., Ltd.
Coronary Artery Disease, High-risk Percutaneous Coronary Intervention
Early Feasibility Study of the Supira System in Patients Undergoing HRPCI
The objective of this study is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.
- Conditions
- Coronary Artery Disease, High-risk Percutaneous Coronary Intervention, Interventional Cardiology
- Trial name
- NCT06087575
- Testing
- Supira System
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Supira Medical
Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure
Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use
This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW400 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope.
- Conditions
- Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure, Glioma, Glioblastoma (GBM)
- Trial name
- IMED-GLOW400 (NCT07366892)
- Testing
- GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.
- Where
- 2 sites in Portugal, Switzerland
- Volunteers
- 37 people
- Sponsor
- Leica Microsystems (Schweiz) AG
High-Risk Percutaneous Coronary Intervention (High-risk PCI), Left Ventricular Assist Devices
Interventional Ventricular Assist System for PCI in CHIP Patients
In patients with complex coronary artery disease (CAD), determining the optimal revascularization strategy (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) remains a challenge.
- Trial name
- REC-CHIPMCS (NCT06373120)
- Testing
- Microaxial flow pump, VA-ECMO
- Where
- China
- Volunteers
- 262 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)
The 3D Stent Study
The goal of this observational study is to assess the diagnostic performance of 3D Stent to detect stent under-expansion in patients undergoing percutaneous coronary intervention.
- Trial name
- NCT06898021
- Testing
- 3DStent
- Where
- 4 sites in Belgium, France and 2 more
- Volunteers
- 200 people
- Sponsor
- CoreAalst BV
High-Grade Glioma (WHO III-IV), Cerebral Vascular Conditions Requiring Surgical Intervention
Evaluation of Image Quality and Safety of the MyVeo Surgical Visualization Headset During Standard Neurosurgical and Reconstructive Procedures Using Compatible Microscopes.
This study looks at how well the MyVeo surgical visualization headset works during routine surgeries. MyVeo is a wearable device that helps surgeons see the surgical area in high detail, including blood flow and tissue…
- Conditions
- High-Grade Glioma (WHO III-IV), Cerebral Vascular Conditions Requiring Surgical Intervention, Conditions Requiring Plastic and Reconstructive Surgery
- Trial name
- IMED-MYVEO (NCT07164053)
- Testing
- MyVeo is an all-in-one surgical visualization headset used with compatible surgical microscopes and other medical imaging systems in the area of neurosurgery, ENT, spine, plastic and reconstructive su
- Where
- 2 sites in Spain, Switzerland
- Volunteers
- 32 people
- Sponsor
- Leica Microsystems (Schweiz) AG
Coronary Artery Disease, Percutaneous Coronary Intervention
Effectiveness and Safety of Abluminal Biodegradable Polymer Sirolimus-eluting Stent (GENOSS® DES)
In this study, the investigators evaluated the effectiveness and safety of using the GENOSS® DES, which has a biodegradable polymer only on the inner wall of the blood vessel, for patients(all-comers) with coronary artery disease…
- Trial name
- GENCOMX (NCT06086496)
- Testing
- GENOSS® DES Sirolimus Eluting Coronary Stent System
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Genoss Co., Ltd.
Percutaneous Coronary Intervention, Multivessel Coronary Artery Disease
Safety and Effectiveness of GENOSS® DES in Patients With Multivessel Coronary Artery Disease
The investigators intend to establish a multicenter prospective observational study by enrolling and tracking patients with multivessel coronary artery disease (MVCAD) using Genoss DES, a device manufactured with pure domestic…
- Trial name
- GENOSS-MV (NCT06168305)
- Testing
- GENOSS® DES Sirolimus Eluting Coronary Stent System
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Genoss Co., Ltd.
Acute Myocardial Infarction (AMI), Percutaneous Coronary Intervention (PCI)
Efficacy and Safety of Shexiang Baoxin Pill(MUSKARDIA) in the Treatment of Acute Myocardial Infarction
This study aims to evaluate the value of Shexiang Baoxin Pill (MUSKARDIA) in patients with acute myocardial infarction (AMI) through a prospective, multicenter, pragmatic randomized controlled real-world study.
- Trial name
- MUST Ⅱ (NCT07153744)
- Testing
- Aspirin, Shexiang Baoxin Pill
- Where
- China
- Volunteers
- 9,588 people
- Sponsor
- Shanghai Hutchison Pharmaceuticals Limited
High-Risk Percutaneous Coronary Intervention (High-risk PCI), Left Ventricular Assist Devices
Interventional Left Ventricular Assist System for PCI in CHIP Patients
Mechanical circulatory support (MCS) is a life-sustaining therapy first introduced in the 1950s. After six decades of development, it now serves as a critical bridge therapy for patients with acute cardiac events and end-stage…
- Trial name
- NCT07053618
- Testing
- Implantation of the VADLINK Percutaneous Left Ventricular Assist Device, VA-ECMO
- Where
- 15 sites in China
- Volunteers
- 286 people
- Sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTD
Coronary Artery Disease, Percutaneous Coronary Intervention (PCI)
A Randomized Study of Cutting Balloon Catheter for CAD
This study is designed as a prospective, multi-center, non-inferiority and randomized controlled clinical trial. A total of 158 eligible subjects from 18 sites across the country is planned to be enrolled, and they will be…
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention (PCI), Calcified Coronary Lesions
- Trial name
- NCT07140822
- Testing
- Coronary Cutting Balloon Catheter, VesscideTM Cutting Balloon System
- Where
- China
- Volunteers
- 166 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Coronary Artery Disease (CAD), Percutaneous Coronary Intervention (PCI)
The Efficacy and Safety Evaluation of 5G Tele-PCI Using R-OneTM
Patients with coronary artery disease requiring PCI treatment were enrolled in the study. All patients underwent PCI with the robotic R-OneTM System (R-One Vascular Robotics, Cathbot).
- Trial name
- tele-PCI (NCT07132255)
- Testing
- R-One assisted tele-PCI, R-One assisted on-site PCI
- Where
- 5 sites in China
- Volunteers
- 60 people
- Sponsor
- Cathbot (Shanghai) Robot Co., Ltd
Coronary Artery Disease, Coronary Artery Stenosis
To Evaluate the Performance and Safety of RisoR Crest Everolimus Eluting Coronary Stent System
The study will evaluate the performance and safety of RisoR Crest Everolimus Eluting Coronary Stent System. A total of 2000 participants will be included in the study from India and Italy.
- Conditions
- Coronary Artery Disease, Coronary Artery Stenosis, Percutaneous Coronary Intervention, de Novo Lesions in Native Coronary Arteries
- Trial name
- PACIFIER (NCT07098195)
- Testing
- Coronary Stent
- Volunteers
- 2,000 people
- Sponsor
- Poly Medicure Limited
Percutaneous Coronary Intervention (PCI), Coronary Artery Disease
A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial to Evaluate the Safety and Efficacy of IVUS Console and IVUS Catheter in Coronary Intervention Procedures
The goal of this clinical trial is to evaluate the safety and efficacy of IVUS Console and IVUS Catheter in coronary intervention therapy Participants will: Undergo IVUS examinations from two different manufacturers（from Pulse…
- Trial name
- IVUS (NCT06974760)
- Testing
- IVUS
- Where
- 4 sites in China
- Volunteers
- 150 people
- Sponsor
- Pulse Medical Imaging Technology (Shanghai) Co., Ltd
Percutaneous Intervention Via Femoral Artery
Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures
The purpose of this study is to evaluate the effectiveness and safety of the suture-mediated closure system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. following endovascular peripheral arterial procedures.
- Trial name
- NCT05899478
- Testing
- Tyknot® Suture-Mediated Closure System, Perclose® ProGlide Suture-Mediated Closure System
- Where
- 5 sites in China
- Volunteers
- 135 people
- Sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTD
High-risk Percutaneous Coronary Intervention, Heart Disease, Coronary
VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)
The VITALYST Early Feasibility study (EFS) is designed to evaluate the feasibility and safety of the VITALYST System in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).
- Trial name
- VITALYST EFS (NCT06132568)
- Testing
- VITALYST System
- Where
- 5 sites in United States, Sweden
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
High-Risk Percutaneous Coronary Intervention
Magenta Elevate™ First-in-Human Clinical Study in High-Risk PCI Patients
The Elevate™ First-In-Human (FIH) study is designed to evaluate the initial safety and device functionality of the Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk…
- Trial name
- ELEVATE I (NCT06099548)
- Testing
- The Elevate™ System
- Where
- 2 sites in Georgia
- Volunteers
- 20 people
- Sponsor
- Magenta Medical Ltd.
Any Disease Which Requires Peripheral Endovascular Intervention
SENTANTE: Fully Robotic Peripheral Endovascular Interventions
The objective of the study is to evaluate the feasibility, safety and initial efficacy of the clinical and technical performance of the SENTANTE robotic system in the remote delivery and manipulation of commonly used and…
- Trial name
- ESSENTIAL (NCT06537947)
- Testing
- Endovascular intervention using the SENTANTE endovascular robotic system
- Where
- Latvia
- Volunteers
- 10 people
- Sponsor
- Inovatyvi Medicina UAB
Cognitive Intervention to Promote Healthy Development of Executive Function (EF) Skills in Young Children
Parent-Child EF Intervention
Koronis Biomedical Technologies Corporation (KBT) is developing a cognitive intervention to promote healthy development of Executive Function (EF) skills in young children by leveraging a smartphone-based training regime designed…
- Trial name
- NCT06924307
- Testing
- Executive Function Intervention
- Where
- 2 sites in United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Koronis Biomedical Technologies
Percutaneous Coronary Intervention, Dual Antiplatelet Therapy
Efficacy and Safety of Short Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease
The objective of study is to evaluate the efficacy and safety of short duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease.
- Trial name
- DAPTShort (NCT06075420)
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Genoss Co., Ltd.