Clinical trials: High-Risk Percutaneous Coronary Intervention
- Condition High-Risk Percutaneous Coronary Intervention
- Funder type Industry (pharma, biotech, devices)
Complex Coronary Lesions
Intravascular Ultrasound Guidance for Complex High-risk Indicated Procedures
The IVUS CHIP trial is a post-marketing strategy study in which patients with complex coronary lesions, undergoing percutaneous coronary intervention (PCI), are treated either with intravascular ultrasound (IVUS) guided PCI or…
- Trial name
- IVUS-CHIP (NCT04854070)
- Testing
- IVUS, Angio
- Where
- 37 sites in Belgium, France and 5 more
- Volunteers
- 2,020 people
- Sponsor
- ECRI bv
Coronary Artery Disease, Percutaneous Coronary Intervention
Efficacy and Safety of 1-year Duration of DAPT After GENOSS® DES Implantation in Patients with Coronary Artery Disease According to the Complex Higher-risk Procedure
The objective of study is to evaluate the efficacy and safety of 1 year duration of DAPT after GENOSS® DES Implantation in patients with coronary artery disease according to the complex higher-risk (and indicated) procedure.
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, Dual Antiplatelet Therapy
- Trial name
- DAPTLong (NCT06075433)
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Genoss Co., Ltd.
Coronary Artery Disease
Bioflow-DAPT Study
BIOFLOW-DAPT is a prospective, multi-center, international, two-arm randomized controlled clinical study. A total of 1'948 subjects will be randomized 1:1 to receive either Orsiro Mission or Resolute Onyx.
- Trial name
- NCT04137510
- Testing
- Percutaneous coronary intervention
- Where
- 53 sites in Australia, Austria and 16 more
- Volunteers
- 1,948 people
- Sponsor
- Biotronik AG
Heart Diseases, Coronary Artery Disease (CAD)
Feasibility Study SA of the Supira System for HRPCI
The objective is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing high-risk percutaneous interventions (HRPCI).
- Conditions
- Heart Diseases, Coronary Artery Disease (CAD), Heart Failure
- Trial name
- NCT05864248
- Testing
- Supira System
- Where
- 2 sites in Brazil
- Volunteers
- 71 people
- Sponsor
- Supira Medical
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
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
PMCF Study for Cardiology Access Procedures
This Post-market clinical follow-up (PMCF) study is designed as retrospective, multi-center study to collect real-life data. A multi-center design is used to ensure a representative sample of the physicians who have performed the…
- Trial name
- NCT05543096
- Testing
- Adroit Guiding Catheter, Cordis Transradial Access Devices, Cordis Diagnostic Catheters, Cordis Guidewires
- Where
- 8 sites in Austria, Belgium
- Volunteers
- 200 people
- Sponsor
- Cordis US Corp.
Coronary Artery Disease, Chronic Stable Angina
LEADERS FREE IV (RCT): BioFreedom™ Ultra vs BioFreedom™ in HBR Patients
This study aims to demonstrate that the BioFreedom™ Ultra Drug Coated Stent (DCS) is non-inferior to the BioFreedom™ DCS, with respect to in-stent late lumen loss, and that it has safety characteristics similar to the BioFreedom™…
- Conditions
- Coronary Artery Disease, Chronic Stable Angina, Unstable Angina, Silent Ischemia
- Trial name
- NCT06657326
- Testing
- BioFreedom™ Ultra cobalt-chromium Biolimus A9™-coated stent, BioFreedom™ stainless steel Biolimus A9™-coated stent
- Where
- 6 sites in Malaysia
- Volunteers
- 444 people
- Sponsor
- Biosensors Europe SA
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.
Acute Coronary Disease, Angina Unstable
Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS
The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin (two doses) will decrease the risk of ischemic complications (cardiac death (CV death), myocardial infarction (MI), stroke) after a…
- Trial name
- CURRENT/OASIS7 (NCT00335452)
- Testing
- Clopidogrel, acetylsalicyclic acid (ASA)
- Where
- 38 sites in United States, Argentina and 36 more
- Volunteers
- 25,086 people
- Sponsor
- Sanofi
Acute Coronary Syndrome, Type 2 Diabetes
A Phase 2 Study to Determine the Effects of BXT-51072 in Diabetic Patients Undergoing Angioplasty (PCI)
The purpose of this study is to determine the safety and feasibility of BXT-51072 as a cardioprotective agent in diabetics undergoing elective angioplasty / percutaneous intervention (PCI), a procedure to "open" coronary…
- Trial name
- NCT00320502
- Testing
- BXT-51072
- Where
- 4 sites in Israel
- Volunteers
- 60 people
- Sponsor
- Synvista Therapeutics, Inc
Acute Myocardial Infarction (AMI), Asystole
SPIKE FLOW Endocardial Lead Safety and Performance Study
The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead. Primary objectives are to assess: safety in terms of freedom from Serious Adverse Events(SADEs); performance in terms of Mean…
- Conditions
- Acute Myocardial Infarction (AMI), Asystole, Bradycardia, AV Block
- Trial name
- SPIKE FLOW (NCT07820072)
- Testing
- Lead insertion, lead removal
- Where
- 3 sites in Italy
- Volunteers
- 131 people
- Sponsor
- FIAB SpA
Ventricular Assist Device
A Safety and Effectiveness Study of the Supira System in Patients Undergoing HRPCI - CE Study
The objective of this study is to evaluate the safety and effectiveness of utilizing the Supira System to provide hemodynamic support during HRPCI.
- Trial name
- SUPPORT CE (NCT06565039)
- Testing
- Supira System
- Sponsor
- Supira Medical
Heart Disease, Coronary Arterial Disease (CAD)
Feasibility Study of the Supira System in Patients Undergoing HRPCI With Support Beyond the PCI Procedure
The objective of this study is to assess the safety and feasibility of the Supira System in heart failure patients with low LVEF, undergoing HRPCI with use of mechanical circulatory support who may benefit from cardiovascular…
- Conditions
- Heart Disease, Coronary Arterial Disease (CAD), Heart Failure
- Trial name
- NCT07407816
- Testing
- Supira System
- Where
- 2 sites in Georgia
- Volunteers
- 45 people
- Sponsor
- Supira Medical
Coronary Artery Disease
Phitys I™ Percutaneous Left Ventricular Assist System Study
The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus intra-aortic balloon pump (IABP) for Circulatory Support during High-risk PCI.
- Trial name
- NCT06357026
- Testing
- Percutaneous Ventricular Assist System（Phigine Medical）, intra-aortic balloon pump (IABP)
- Where
- 8 sites in China
- Volunteers
- 344 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
High-Risk Percutaneous Coronary Intervention
Impella ECP Study (ECP Study) and Impella ECP Continued Access Protocol
The Impella ECP Study is a prospective, multi-center, single-arm study evaluating the rate of major adverse cardiovascular and cerebrovascular events (MACCE) with the Impella ECP device in adult patients undergoing elective or…
- Trial name
- NCT05334784
- Testing
- Impella ECP
- Where
- 32 sites in United States
- Volunteers
- 856 people
- Sponsor
- Abiomed Inc.
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
Myocardial Infarction, Acute Coronary Syndromes
Shortened Aggrastat® Versus Integrilin in Percutaneous Coronary Intervention
The purpose this study is to assess whether a tirofiban regimen of a high-dose bolus plus a shortened infusion duration compared to label-dosing eptifibatide in patients undergoing percutaneous coronary intervention (PCI) is…
- Conditions
- Myocardial Infarction, Acute Coronary Syndromes, Unstable Angina
- Trial name
- SAVI-PCI (NCT01522417)
- Testing
- Short Tirofiban, Eptifibatide, Long Tirofiban
- Where
- 13 sites in United States
- Volunteers
- 535 people
- Sponsor
- Medicure
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 PCI
Evaluate the Effectiveness and Safety of the OmniHeart 4.0 Percutaneous Ventricular Assist Device in Providing Hemodynamic Support for Patients Undergoing High-risk Percutaneous Coronary Intervention (PCI).
The objective of this clinical trial is to understand the effectiveness and safety of the OmniHeart 4.0 percutaneous ventricular assist device produced by ShanghaiDynaheart Medical Technology Co., Ltd.
- Trial name
- NCT07622446
- Testing
- OmniHeart 4.0 Percutaneous Ventricular Assist Device, ECMO
- Where
- 2 sites in China
- Volunteers
- 254 people
- Sponsor
- Shanghai Dynaheart Medtech Co., Ltd.