Gangneung

Researchers are comparing two methods for guiding complete revascularization in patients with significant coronary artery disease undergoing percutaneous coronary intervention (PCI) using drug-eluting stents. The study evaluates anatomical guidance using quantitative coronary angiography (QCA) versus physiological guidance using fractional flow reserve (FFR) to determine which approach leads to better clinical outcomes. This open-label, randomized trial includes patients with symptomatic or ischemic evidence and coronary artery lesions suitable for PCI. Participants are randomly assigned to either the QCA-guided group, where PCI is performed on lesions with diameter stenosis of 50% or more as measured by QCA, or the FFR-guided group, where PCI is performed on lesions with FFR values of 0.80 or less. Imaging guidance during PCI is left to the operator's discretion, with routine high-pressure post-dilation recommended to optimize stent expansion. Follow-up visits occur at 1, 6, and 12 months, with continued observation up to 5 years after the initial procedure. During the study, researchers will monitor and evaluate clinical outcomes such as death, myocardial infarction, and repeat unplanned revascularization within 12 months. Participants will undergo clinical assessments at scheduled follow-ups to track safety and effectiveness. The study aims to provide insights into the best guidance strategy for complete revascularization in patients with coronary artery disease treated with drug-eluting stents.

Researchers are evaluating the use of machine learning-based models derived from coronary angiography and intravascular ultrasound (IVUS) to improve decision making and stent optimization in patients with coronary artery disease. This multicenter, prospective study plans to enroll 3,000 patients from 15 centers in South Korea between January 2020 and June 2025. The study focuses on both treated coronary lesions requiring stent implantation and deferred lesions with more than 30% stenosis to assess the models' diagnostic performance and clinical impact. Participants will undergo percutaneous coronary intervention (PCI) guided by IVUS to implant stents. The study uses supervised machine learning algorithms to predict fractional flow reserve (FFR), characterize plaques, predict stent expansion, and forecast stent failure after implantation. Both culprit (treated) and nonculprit (deferred) coronary lesions will be monitored, with the primary goal of evaluating target vessel failure (TVF) related to these lesions over two years. During the study, participants will be closely followed for two years after their stent implantation. Researchers will assess clinical outcomes related to treated and deferred lesions, focusing on the occurrence of target vessel failure. The study involves detailed imaging and algorithm evaluation to determine the prognostic impact of the new AI technologies on event reduction following PCI.

Researchers are comparing two heart procedures — a modern, imaging- and physiology-guided percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) — in people with type 2 diabetes who have significant disease in three heart arteries but not the left main artery. This study focuses on patients with diabetes and three-vessel coronary artery disease to determine which treatment approach results in better outcomes over two years. One group receives PCI guided by advanced imaging techniques like intravascular ultrasound or optical coherence tomography and physiological measurements such as fractional flow reserve or instantaneous wave-free ratio. They are treated with modern drug-eluting stents and receive optimal medical therapy including high-dose statins, advanced antiplatelet regimens, and anti-diabetic medications like SGLT-2 inhibitors or GLP-1 agonists. The other group undergoes standard coronary artery bypass surgery (CABG). Both treatments aim to restore blood flow in the affected arteries. Participants are followed for two years to monitor major adverse cardiac or cerebrovascular events. The study includes clinical follow-ups and assessments to evaluate the safety and effectiveness of the procedures combined with medical therapy. Patients must consent to the study protocol and follow-up schedule. This research helps understand the best revascularization strategy for diabetic patients with complex coronary artery disease.

Researchers are investigating the outcomes of stopping versus continuing antiplatelet medication in patients with chronic coronary syndrome who have a high risk of bleeding and were treated with drug-coated balloon (DCB) angioplasty. The study focuses on those who have completed a standard dual antiplatelet therapy (DAPT) period of 1 to 3 months followed by at least one year of single antiplatelet therapy without any clinical events. This trial addresses the gap in evidence regarding lifelong antiplatelet use in this particular group, aiming to establish better guidelines for post-treatment care. Participants are randomly assigned one year after their initial DCB angioplasty and standard DAPT treatment to either stop antiplatelet medication or continue lifelong single antiplatelet therapy. For those still on DAPT at randomization, the study protocol either discontinues all antiplatelet drugs or switches to a single antiplatelet agent, chosen by the physician. This open-label, multi-center trial compares these two strategies to determine the best approach for managing antiplatelet therapy in high bleeding risk patients. During the study, participants will be monitored for major bleeding events one year after the last patient enrollment. Researchers will assess safety and efficacy by tracking bleeding incidents classified as BARC types 2, 3, or 5. The trial includes regular follow-ups and evaluations to monitor the participants' health status and treatment outcomes over time, aiming to provide evidence for safer and more effective antiplatelet management after DCB angioplasty in this population.

Researchers are evaluating whether a new drug called Enavogliflozin, taken once daily at 0.3 mg, can better reduce major heart problems and heart failure events compared to a placebo. This study focuses on patients who have severe aortic valve narrowing and have had a transcatheter aortic valve replacement (TAVR). All patients also have heart failure with preserved ejection fraction, meaning their heart pumps normally but they experience heart failure symptoms. This is a phase 4 trial exploring the safety and effectiveness of adding Enavogliflozin to usual care. Participants are randomly assigned to receive either Enavogliflozin 0.3 mg once daily or a placebo, in addition to their standard medical treatment. The study compares these two groups to see which better prevents major cardiovascular events or worsening heart failure. Treatment is double-blinded, so neither patients nor researchers know who gets the drug or placebo during the trial. The study lasts for at least 12 months after randomization. Throughout the study, researchers will monitor participants to record the time until they experience a major heart problem or are hospitalized for heart failure. This includes tracking heart health and any hospital visits related to heart failure. Safety and effectiveness data will be collected during this period. Participants will be regularly assessed to ensure their heart function and overall health are carefully observed during the trial.

Objective of this study is to 1) analyze the clinical, anatomical and periprocedural differences of patients who underwent a procedure related to coronary CTO through the antergrade approach and retrograde approach; 2) analyze the success rate of the procedures and the incidence and patterns of complications; 3) compare and analyze long-term performances after the successful procedure; and 4) identify the independent factors that require a retrograde approach and the prognostic factor regarding long-term performances after use of each approach.

This research aims to assess the effectiveness and safety of two specific stents, the Synergy XD stent and Synergy Megatron194 Stent, compared to other drug-eluting stents in patients with coronary artery disease. The study is a non-randomized, prospective, open-label registry designed to observe real-world daily practice outcomes in patients with various cardiovascular and heart diseases including myocardial ischemia and coronary disease. Participants will receive treatment through percutaneous coronary intervention using either the Synergy XD stent or the Synergy Megatron194 Stent. The study compares these devices against other drug-eluting stents. It is an observational study conducted across multiple centers without random assignment, focusing on routine clinical use of these stents. Throughout the study, researchers will monitor participants for the composite event rate of death, non-fatal myocardial infarction, or target vessel revascularization over one year. Participants will undergo clinical follow-up evaluations according to the study protocol, with data collected on safety and effectiveness outcomes. Informed consent is required, and participant involvement includes scheduled clinical assessments and monitoring for cardiovascular events.

This research aims to evaluate the effectiveness and safety of the Ultimaster17 Tansei17 stent in patients with coronary artery disease during routine clinical practice. The study focuses on real-world daily use of this stent to better understand its outcomes in typical healthcare settings. Participants in this study will receive the Ultimaster17 Tansei17 stent as part of their treatment. The study is observational and takes place across multiple centers, with patients being monitored after receiving the stent. There are no comparison groups; the focus is on those treated with this specific stent. During the study, researchers will follow patients closely, assessing major outcomes such as death, nonfatal heart attacks, or the need for repeat procedures on the treated blood vessel within one year. Participants will have clinical follow-ups according to the study schedule, and safety and effectiveness data will be collected throughout this period to provide a comprehensive view of the stent's performance in everyday medical care.

Researchers are evaluating whether the 2-year chance of major adverse cardiac events differs between two methods of guiding Percutaneous Coronary Intervention (PCI) in patients with Left Main Coronary Artery disease. The study compares Fractional Flow Reserve (FFR)-guided PCI to angiography-guided PCI to better understand treatment decision-making for this heart condition. Participants will be divided into two groups receiving either FFR-guided PCI or angiography-guided PCI. Both are procedures used to treat significant narrowing in the left main coronary artery. The study involves monitoring each participant's health and event occurrences over a two-year period. Throughout the study, all participants will be closely monitored until their last scheduled visit, which may occur up to two years after treatment. Researchers will check for any major cardiac events during this time to assess differences between the two treatment approaches. The primary measure is the combined rate of these events over the two years.

Coronary artery disease (CAD) is the most prevalent and lethal disease worldwide. Even though various studies have been performed regarding the prevention or treatment of CAD and its related cardiovascular events, the prevalence of CAD and the incidence of cardiovascular events are increasing. Antiplatelet agents are among the most widely used drugs for preventing cardiovascular events. The efficacy of antiplatelet agents has been extensively proven in secondary prevention for cardiovascular events in CAD patients, and their use has been recommended in current guidelines. However, there is still controversy surrounding the prescription of antiplatelet agents for the primary prevention of cardiovascular events in CAD patients due to their unknown clear efficacy and risk of bleeding complications. Recent studies reported the limited efficacy of aspirin in old patients, diabetes patients, or patients with cardiovascular events risks. However, the efficacy or safety of antiplatelet therapy in patients with subclinical coronary atherosclerosis has not been thoroughly investigated. These patients are at higher risk of cardiac death or myocardial infarction compared to patients without coronary atherosclerosis. In this regard, the investigators will evaluate the efficacy and safety of clopidogrel for primary prevention in patients diagnosed with coronary atherosclerosis on imaging that did not require revascularization therapy.