Clinical trials: High Risk PCI, active
Coronary Artery Disease
Relationship Between Coronary CT Angiography Findings and Prognosis Of Patients Undergoing PCI
Researchers at Cerrahpaşa Medical School in Istanbul are studying how a heart imaging test called coronary CT angiography can help improve care for people with coronary artery disease.
- Trial name
- NCT07051473
- Where
- Turkey (Türkiye)
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Istanbul University - Cerrahpasa
Left Ventricular Dysfunction, Coronary Artery Disease
Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health…
- Trial name
- PROTECT IV (NCT04763200)
- Testing
- Impella CP® / Impella CP® with SmartAssist® / Impella 2.5®, IABP Intra-aortic balloon pump
- Where
- 110 sites in United States, Canada and 5 more
- Volunteers
- 1,252 people
- Sponsor
- Abiomed Inc.
Coronary Artery Disease
Prognosis and Antiplatelet Strategies for Patients With PCI and High Bleeding Risk:A Study Protocol
Percutaneous coronary intervention (PCI) is an important treatment strategy for patients with coronary artery disease. Combined bleeding after PCI significantly increases the risk of death in patients.
- Trial name
- NCT05369442
- Where
- China
- Volunteers
- 1,300 people
- Sponsor
- West China Hospital
Acute Coronary Syndrome (ACS), High Bleeding Risk (HBR)
Optimization and Validation of Quality Control Indicators for Coronary Revascularization Based on Antiplatelet Therapy
Study Purpose Coronary heart disease (CAD) is a leading global cause of death, with Acute Coronary Syndrome (ACS) as its acute and life-threatening subtype.
- Conditions
- Acute Coronary Syndrome (ACS), High Bleeding Risk (HBR), Coronary Artery Disease (CAD)
- Trial name
- NCT07354828
- Where
- China
- Volunteers
- 3,500 people
- Sponsor
- Shenyang Northern Hospital
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
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
ECMO, High-risk PCI
Standby Cannulated ECMO for High-Risk Percutaneous Coronary Intervention
The goal of this multicenter, randomized trial is to compare standby cannulated ECMO versus prophylactic ECMO in patients undergoing high-risk percutaneous coronary intervention (PCI).
- Trial name
- ECMO-READY (NCT06274411)
- Testing
- Standby cannulated ECMO, Prophylactic ECMO
- Where
- China
- Volunteers
- 176 people
- Sponsor
- Beijing Anzhen Hospital
Coronary Artery Disease, Percutaneous Coronary Intervention
Potassium-Competitive Acid Blocker Versus pROton-Pump Inhibitor for GastroproTECTion Strategies In Patients at High Gastro-Intestinal Bleeding Risk Receiving Antithrombotic Therapy
The primary aim of this study is to evaluate the efficacy and safety of novel P-CAB (tegoprazan 50 mg once daily) as compared with standard PPI (rabeprazole 20 mg once daily) for protection of GI events in patients with known…
- Conditions
- Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Coronary Syndrome, Myocardial Infarction
- Trial name
- PROTECT-HBR (NCT04416581)
- Testing
- PPI, P-CAB 50
- Where
- 45 sites in South Korea
- Volunteers
- 3,320 people
- Sponsor
- Duk-Woo Park, MD
ST-segment Elevation Myocardial Infarction (STEMI)
Thrombus Aspiration in STEMI Patients With High Thrombus Burden
This is a prospective, multicenter, open-label, randomized, controlled, parallel group study, in which ST-segment Elevation Myocardial Infarction (STEMI) patients with high thrombus burden(TIMI thrombus grade ≥3) are included.
- Trial name
- NCT04212494
- Testing
- Thrombus aspiration, PCI Alone
- Where
- 50 sites in China
- Volunteers
- 3,838 people
- Sponsor
- Guangdong Provincial People's Hospital
Chronic Coronary Syndrome, Acute Coronary Syndromes
Optimal LDL-C Target in High-risk Patients After PCI
Extensive evidence from epidemiological, genetic, and randomized controlled trials (RCTs) of lipid-lowering therapies has firmly established a causal relationship between low-density lipoprotein cholesterol (LDL-C) and…
- Conditions
- Chronic Coronary Syndrome, Acute Coronary Syndromes, Percutaneous Coronary Intervention, High Risk Patient
- Trial name
- REC-SAFETARGET (NCT06821711)
- Testing
- Intensive LDL-C control, Conventional LDL-C control
- Where
- China
- Volunteers
- 12,000 people
- Sponsor
- Xijing Hospital
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.
Coronary Artery Disease, Ischemic Heart Disease
Ultrathin Strut Sirolimus-eluting Stent With Bioabsorbable Polymer in Patients Receiving Chronic Oral Anticoagulation
Patients receiving chronic oral anticoagulation with indication for percutaneous coronary revascularization with stent implantation, and needing for antiplatelet therapy, are at high risk of bleeding.
- Trial name
- ACO_FLEX (NCT06863155)
- Testing
- Supraflex Cruz Sirolimus-eluting Stent
- Where
- 13 sites in Spain
- Volunteers
- 500 people
- Sponsor
- Fundación EPIC
ST-segment Elevation Myocardial Infarction (STEMI)
Bivalirudin with Prolonged Infusion During PCI Versus Heparin After Fibrinolytic Therapy
This multicenter, randomized controlled trial in China aims to enroll 2,400 patients with ST-segment elevation myocardial infarction undergoing percutaneous coronary intervention (PCI) within 24 hours post-fibrinolysis.
- Trial name
- BRIGHT-FIT (NCT06861374)
- Testing
- Bivalirudin, Unfractionated heparin
- Volunteers
- 2,400 people
- Sponsor
- First Affiliated Hospital Xi'an Jiaotong University
Acute Myocardial Infarction, Heart Failure
Peri-treatment of SGLT-2 Inhibitor on Myocardial Infarct Size and Remodeling Index in Patients With Acute Myocardial Infarction and High Risk of Heart Failure Undergoing Percutaneous Coronary Intervention
We aimed to identify whether SGLT-2 inhibitor administration before and after coronary intervention is effective in reducing the size of infarction and myocardial remodeling in patients with acute myocardial infarction (AMI) and…
- Trial name
- PRESTIGE-AMI (NCT04899479)
- Testing
- SGLT2 inhibitor, Control
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- Samsung Medical Center
Acute Myocardial Infarction (AMI)
Coronary and Myocardial Evaluation by Cardiac CT for Acute Myocardial Infarction
Acute myocardial infarction (AMI) remains a major cause of mortality and morbidity worldwide. Although percutaneous coronary intervention (PCI) combined with guideline-directed medical therapy has substantially improved survival…
- Trial name
- COMET-AMI (NCT07537296)
- Testing
- Cardiac CT Follow-up and Echocardiographic Follow-up
- Where
- 2 sites in China
- Volunteers
- 1,000 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
High-risk PCI
SAVE-PCI Ⅱ: NyokAssist™ Small-Bore VAD vs. ECMO in Elective High-Risk PCI
SAVE-PCI Ⅱ is a prospective, multi-center, randomized controlled trial evaluating the safety and efficacy of NyokAssist™, a small-bore percutaneous ventricular assist device (pVAD), in comparison with ECMO in patients undergoing…
- Trial name
- NCT07860671
- Testing
- NyokAssist, ECMO
- Where
- 14 sites in China
- Volunteers
- 204 people
- Sponsor
- magAssist, Inc.
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.
Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI)
Dual Antiplatelet Therapy Escalation From Standard-dose Clopidogrel to Low-Dose Prasugrel in Patients With High Bleeding and Ischemic Risk Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study (TAILOR-BLEED-2)
The primary aim of this study is to investigate the PD effects of switching from standard-dose clopidogrel dose to low-dose prasugrel versus continuing standard-dose clopidogrel in patients at dual-risk (HBR defined as the…
- Trial name
- NCT07025148
- Testing
- Prasugrel, Clopidogrel
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Florida
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 PCI, Coronary Artery Disease Risk High
Use of Mechanical Left ventricuLar Unloading in Complex Higher-risk Indicated Procedures
If there is a narrowing or blockage in the coronary arteries of the heart, the cardiologist may choose to treat this blockage. This is called percutaneous coronary intervention (PCI), which involves both balloon angioplasty and…
- Trial name
- UNLOAD-CHIP (NCT07380217)
- Testing
- Mechanical circulatory support with the Pulsecath iVAC2L device
- Where
- 8 sites in Netherlands
- Volunteers
- 98 people
- Sponsor
- Amsterdam UMC, location VUmc