A Clinical Investigation to Evaluate the Safety and Efficacy of IBS in Patients With Coronary Artery...
Coronary Artery DiseaseA prospective, multi-center, single-blinded, randomized trial to assess the safety and efficacy of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS) in treating patients with coronary artery disease compared to the Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE).
Early Detection of Silent Myocardial Ischemia
Ischemic Heart DiseaseSilent Myocardial Ischemia1 moreEarly-Synergy investigates a diagnostic imaging approach in asymptomatic individuals from the general population for early detection of silent myocardial ischemia and cardiac dysfunction. The diagnostic imaging approach consists of cardiac computed tomography for coronary artery calcium scoring (CT-CAC) and cardiac magnetic resonance (CMR) stress perfusion imaging. Early-Synergy investigates the effect of early detection of silent myocardial ischemia and cardiac dysfunction by CMR in asymptomatic individuals with increased CAC. In addition, the diagnostic yield of CMR for early detection of silent myocardial ischemia and cardiac dysfunction is investigated. Asymptomatic individuals at increased risk (CAC ≥ 300) are therefore randomized 1:1 to either CMR stress perfusion imaging or a control group.
Compare Sirolimus Coated Balloon Catheter With Paclitaxel Coated Balloon Catheter in De Novo Coronary...
Coronary Artery DiseaseThe purpose of this study is to evaluate the efficacy and safety of Microport sirolimus drug coated balloon catheter for the treatment of coronary bifurcation lesions.
Intracoronary Infusion of Mononuclear Cells Autologous Bone Marrow in Patients With Chronic Coronary...
Coronary Atherosclerosis and Other Heart DiseaseClinical trial phase III, prospective, controlled, randomized, open. We hypothesize work that patients with chronic coronary occlusion and poor myocardial viability who failed to recover ventricular function after subjecting coronary revascularization with new techniques of recanalization, could achieve an improvement of ventricular function if given further regenerative treatment with mononuclear cells from autologous bone marrow. To test this hypothesis we designed a prospective, randomized clinical trial in patients with recanalized chronic occlusions and ventricular dysfunction.
Effect of Remote Ischemic Preconditioning in Patient Undergoing Cardiac Bypass Surgery
Coronary Heart DiseaseDuring coronary artery bypass graft surgery, injury occurs to the heart muscle. Some of this injury is due to the deprivation of oxygen and nutrients to the heart (a process called ischemia) during the surgery itself. The objective of this study is to examine whether remote ischaemic preconditioning (RIPC), in which the application of transient ischemia to the forearm and thigh (through the inflation of blood pressure cuffs placed on the right upper arm and upper thigh) may reduce the injury to the heart muscle sustained during cardiac surgery. The study hypothesis is: remote ischemic preconditioning will protect the heart and improve short-term clinical outcomes during coronary artery bypass graft surgery.
Paclitaxel-coated Balloon for Treatment of De-novo Non-complex Coronary Artery Lesions
De Novo StenosisCoronary Artery DiseaseThe introduction of Bare-metal stents (BMS) since 1986 has alleviated the limitations of plain old balloon angioplasty (POBA) related elastic recoil and flow-limiting dissections. Later on, higher restenosis rates due to exaggerated neointimal growth in BMS has led to the development of drug-eluting stents (DES), which elutes an antiproliferative drug to the vessel wall and reduce the restenosis rate. However, late stent thrombosis and restenosis, with a hazard of nearly 2% per year after implantation, remained a concern and motivated the development of drug-coated balloons (DCB). The advantages of DCB are that leaving no metal in the blood vessel and respect the vessel anatomy. Recently, studies with the strategy of DCB angioplasty with bailout stenting have demonstrated safety and efficacy for the small-vessel disease. In the BASKET-SMALL 2 trial, which compared SeQuent Please DCB with EES or Taxus DES in the vessels that have reference diameter<3mm, showed that at 12-month follow-up, DCB was non-inferior to DES (MACE [cardiac death, non-fatal myocardial infarction, and target-vessel revascularisation] rates: 8% vs. 9%). Although some small-scale RCT using surrogate endpoints have reported that no significant difference in MLD or late lumen loss between the two groups in large vessels, up to now, there is no large-scale RCT comparing the clinical outcomes of DCB versus DES in large vessels with de novo lesions. Therefore, the investigators hypothesized that in patients undergoing non-complex percutaneous coronary intervention (PCI) for de-novo stenoses, drug-coated balloon (DCB) is non-inferior to drug-eluting stents (DES). Besides the ischemic events to be observed, there might be also a potential benefit of the DCB strategy by reducing the bleeding events. Although there is scarce evidence showing the optimal DAPT duration for DCB, in the current study, according to our empirical clinical experiences and previous expert consensus, the investigators chose aspirin + Ticagrelor/Clopidogrel for 3-month followed by Ticagrelor/Clopidogrel monotherapy for 3-month to be the antiplatelet regimen in DCB arm. In contrast to the antiplatelet regimen for the DES arm used in the current trial, which is aspirin + Ticagrelor/Clopidogrel for 3-month followed by Ticagrelor/Clopidogrel monotherapy for 9-month, the DCB and its antiplatelet strategy is estimated to reduce the bleeding events during follow-up.
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Chinese Patients With...
Coronary Artery DiseaseThe purpose of this study is to evaluate the safety and efficacy of Genoss® DCB by demonstrating non-inferiority in patients with in-stent restenosis (ISR) compared with a product of the same category (Sequent® Please NEO). The experimental group was treated with Genoss® DCB, and the control group was treated with SeQuent® Please NEO. In this study, the end point of 9 months after procedure was used as the main endpoint to evaluate the efficacy of Paclitaxel coated PTCA balloon catheter. The safety of the catheter was evaluated by cardiovascular adverse events.
Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction...
Coronary Heart Disease (CHD)This study will assess the effect of lowering low-density lipoprotein cholesterol (LDL-C) with evolocumab on major cardiovascular events in adults without a prior myocardial infarction (MI) or stroke who are at high risk of a cardiovascular event.
Edoxaban Versus Edoxaban With antiPlatelet Agent In Patients With Atrial Fibrillation and Chronic...
Atrial FibrillationCoronary Artery Disease2 moreThis study evaluates the efficacy and safety of Edoxaban with the combination of edoxaban and antiplatelet in patients with stable CAD (coronary artery stenosis ≥50% on medical treatment or revascularized stable CAD [≥ 12 months for acute coronary syndrome and ≥ 6 months after stable CAD]) and high-risk atrial fibrillation (CHA2DS2-VASc score ≥2).
SYNergy Stent® System Implantation With Mandatory Intra-VascularUltra-Sound Guidance and Dual Anti-Platelet...
Coronary Artery DiseaseAtherosclerosis1 moreThe purpose of this study is to see if one month of dual antiplatelet therapy (DAPT) combined with the placement of the Synergy® Stent with IVUS (intravascular ultrasound) is safe for patients who are at high risk of bleeding (HBR).