Gangneung

This prospective, open-label, multicenter, single-arm, non-interventional, observational surveillance is designed to assess the safety and effectiveness of Atectura inhalation capsule for up to 24 weeks under routine clinical practice. Three different doses of Atectura inhalation capsule will be prescribed via Breezhaler according to the approved label information in Korea. No additional diagnostic or monitoring procedures will be conducted specifically for this study.

Researchers are evaluating two different strategies for complete revascularization in patients with significant coronary artery disease CAD who are undergoing percutaneous coronary intervention PCI with drug-eluting stents DES. The study compares quantitative coronary angiography QCA-guided anatomic complete revascularization and fractional flow reserve FFR-guided physiologic complete revascularization. This prospective, multicenter, randomized trial includes patients with symptoms or evidence of myocardial ischemia and specific stenotic lesions in major coronary arteries. Participants are randomly assigned to either the QCA-guided group, where PCI is performed on lesions with at least 50% diameter stenosis, or the FFR-guided group, where PCI targets lesions with FFR values of 0.80 or less. Imaging guidance during PCI is optional but left to the operators discretion, while routine high-pressure post-dilation is recommended. The study involves an initial procedure with possible staged procedures as needed. Participants will be followed clinically at 1, 6, and 12 months, and then up to 5 years after the initial procedure. Assessments include tracking death, myocardial infarction, unplanned repeat revascularization, bleeding, rehospitalization, and self-rated health. The study aims to collect data on these outcomes to compare the two revascularization strategies in terms of safety, efficacy, and cost-effectiveness over both short- and long-term periods.

Researchers are evaluating the effects of aspirin and high-intensity statin therapy in people with severe coronary calcification, defined as a coronary calcium score of 300 or higher. The trial aims to understand how these treatments may help prevent atherosclerotic cardiovascular disease ASCVD events in this population. This phase 4, randomized, open-label trial uses a factorial design to assess both aspirin use and statin intensity. Participants are assigned to one of four groups aspirin 100 mgday with high-intensity statin therapy no aspirin with high-intensity statin therapy no aspirin with guideline-directed statin therapy or aspirin 100 mgday with guideline-directed statin therapy. Statin intensity follows the 2026 ACCAHA Guideline on the Management of Dyslipidemia. The study treatment lasts for 3 years, during which participants take the assigned medications. Throughout the trial, participants will be monitored for cardiovascular events and safety outcomes over 3 years. The main outcome is the rate of a composite of ASCVD events. Secondary outcomes include rates of individual cardiovascular events, death from any cause, hospitalization for heart failure, major bleeding, and safety endpoints. Participants will provide informed consent and follow the study protocol with scheduled clinical follow-ups to assess these outcomes.

Researchers are evaluating the diagnostic performance and clinical impact of coronary angiography and intravascular ultrasound IVUS-based machine learning ML models in patients with coronary artery disease undergoing percutaneous coronary intervention PCI. This multicenter, prospective study aims to validate these AI-driven tools for decision making and stent optimization by assessing their prognostic effects on treated and deferred coronary lesions. The study will enroll 3,000 patients from 16 centers between January 2020 and June 2027. Participants will undergo coronary angiography with or without fractional flow reserve FFR measurement and IVUS imaging. The study evaluates ML algorithms including angiography- and IVUS-based models predicting FFR, plaque characterization, stent expansion, and post-stenting stent failure. The trial focuses on two primary objectives the impact of the integrated ML model on 2-year target vessel failure TVF related to treated culprit lesions and deferred nonculprit lesions. During the study, researchers will monitor participants over two years after stent implantation to measure outcomes such as culprit- and nonculprit-related TVF. Additional outcomes include death from any cause, repeat revascularization, stroke, and bleeding events. Data from coronary imaging, clinical evaluations, and follow-up visits will be collected to assess the clinical value of the AI models and their influence on patient outcomes.

Researchers are evaluating the efficacy and safety of autologous Mesenchymal Stem Cells MSC injected into the hepatic artery for patients with alcoholic liver cirrhosis. This phase III clinical trial aims to assess the effects of a single dose of Cellgram-LC on patients with this condition, focusing on outcomes up to 60 months after treatment. The study is sponsored by Pharmicell Co., Ltd. and involves patients diagnosed with alcoholic cirrhosis who meet specific clinical criteria. Participants are randomly assigned to one of two groups one receiving best supportive care without intervention, and the other receiving a single injection of 7x107 autologous bone marrow-derived mesenchymal stem cells Cellgram-LC delivered directly into the liver through the hepatic artery. The injection is performed within one month after bone marrow extraction. This open-label study monitors patients over several years to evaluate long-term outcomes. During the trial, participants undergo various assessments including survival evaluations, liver function tests, fibrosis measurements, and quality of life questionnaires at multiple time points up to 36 months. Researchers monitor transplant-free survival as the primary outcome over three years. Secondary outcomes include changes in liver severity scores, liver enzyme levels, fibrosis indicators, and health status measures. Safety and efficacy are evaluated throughout the study period, which extends up to five years from treatment.

Researchers are comparing two treatment approaches for patients with diabetes and significant three-vessel coronary artery disease CAD that does not involve the left main artery. This randomized study aims to evaluate outcomes between imaging- and physiology-guided state-of-the-art percutaneous coronary intervention PCI and coronary artery bypass grafting CABG. The trial focuses on how these methods affect major cardiac and cerebrovascular events in this patient group. Participants will receive either PCI guided by advanced imaging and physiological assessments, including intravascular ultrasound IVUS or optical coherence tomography OCT, and tools like fractional flow reserve FFR or instantaneous wave-free ratio iFR, along with modern drug-eluting stents and optimal medical therapy, or they will undergo standard CABG surgery. Both treatments are delivered under careful clinical protocols, and patients will be followed up extensively to assess various health outcomes. During the study, participants will be monitored for major adverse events over two years and other cardiovascular outcomes over five years. Assessments include hospitalization duration, rehospitalization rates, changes in functional class, quality of life questionnaires, medication use, and healthcare costs. The study aims to provide comprehensive data on the effectiveness and safety of these two revascularization strategies, with participants involved in clinical follow-ups and evaluations throughout the study period.

Researchers are evaluating the clinical outcomes of stopping versus continuing antiplatelet therapy in patients with chronic coronary syndrome who have a high risk of bleeding HBR. The study focuses on patients treated with drug-coated balloon DCB angioplasty and standard dual antiplatelet therapy DAPT for 1 to 3 months, followed by maintenance of a single antiplatelet agent for at least one year. This trial explores whether lifelong antiplatelet therapy is necessary after DCB angioplasty in this population, as current evidence mainly involves patients with drug-eluting stents and acute conditions. Participants will be randomly assigned after one year from their DCB angioplasty procedure and standard DAPT. One group will discontinue antiplatelet therapy at randomization, including those still on DAPT, while the other group will continue lifelong antiplatelet monotherapy, either aspirin or clopidogrel, based on physician choice. The study compares these two approaches to better understand post-treatment management in high bleeding risk patients. During the trial, participants will be closely monitored for major bleeding events and other cardiovascular outcomes over one year following the last patient enrollment. Researchers will assess safety and clinical events such as myocardial infarction, death, and revascularization procedures. The study also includes ongoing evaluation of patient status to ensure adherence and track any complications or benefits from the different antiplatelet strategies.

Researchers are studying 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. The study focuses on adults aged 19 and older who have severe aortic stenosis and heart failure with preserved ejection fraction, and who have undergone transcatheter aortic valve replacement TAVR. Participants are randomly assigned to receive either Enavogliflozin or a placebo once daily, along with their usual medical care. The trial compares the effects of these treatments over 12 months to see if Enavogliflozin can reduce heart-related events and hospitalizations for heart failure. The study is double-blind and placebo-controlled, meaning neither participants nor researchers know who is receiving the drug or placebo. During the study, participants will be monitored regularly for heart health, including heart function via echocardiography, blood tests for heart biomarkers, and questionnaires about symptoms and quality of life. Researchers will track major heart events, hospital stays, kidney health, and safety outcomes over one year. The total study duration spans several years, with the primary outcome assessed at 12 months after starting the treatment.

Researchers are studying patients with chronic total occlusion CTO of the coronary artery to compare two different procedural approaches the antegrade and retrograde methods. The study aims to analyze clinical, anatomical, and procedural differences between patients who underwent each approach, evaluate the success rates and complication patterns, and assess long-term outcomes after successful procedures. It also seeks to identify factors that influence the need for the retrograde approach and prognostic factors related to long-term results. Participants are those who have at least one CTO lesion in an epicardial coronary artery with a diameter of 2.5 mm or more and exhibit symptoms of angina or confirmed myocardial ischemia. The study observes patients who underwent either the antegrade or retrograde percutaneous coronary intervention PCI approach. It is an observational study without experimental interventions, focusing on detailed clinical and procedural data collection. The study follows patients for long-term outcomes, with primary measures assessed at 12 months post-PCI and secondary measures annually up to five years. During the study, participant data including procedure success, occurrence of death, myocardial infarction, and target vessel revascularization or reocclusion are tracked. Safety and effectiveness outcomes are evaluated through clinical follow-ups and medical records review. The studys total duration extends up to five years to monitor long-term performance and complications after PCI. Participants provide informed consent and agree to follow-up plans approved by institutional review boards.

Researchers are evaluating the effectiveness and safety of the Synergy XD stent and Synergy Megatron122 Stent compared to other drug-eluting stents in patients with coronary artery disease. This study is a non-randomized, prospective, open-label registry designed to observe how these stents perform in real-world daily medical practice. The study aims to provide important information about outcomes such as death, heart attack, and the need for further vessel treatment. The study involves patients who receive percutaneous coronary intervention using either the Synergy XD stent or the Synergy Megatron122 stent. These devices are compared against other drug-eluting stents used in similar patients. Participants are followed over time with no random assignment to groups, allowing researchers to assess outcomes based on routine clinical care. Participants will be monitored through scheduled clinical follow-ups, with researchers tracking events including death, non-fatal myocardial infarction, and target vessel revascularization over one year. Additional outcomes such as cardiac death, stroke, stent thrombosis, and procedural success are assessed up to five years after treatment. The study collects data on patient safety and effectiveness of these stents during routine use, providing valuable long-term information on their clinical performance.