Active clinical trials for "Coronary Artery Disease"

The purpose of this study is to verify whether additional administration of Alirocumab exerts a stronger stabilizing effect on the vulnerable plaque in CAD, compared with statin alone administration in patients receiving PCI. Therefore, the change in maxLCBI (4 mm) of the coronary artery 9 months after administration by addition administration of Alirocumab is evaluated as the main evaluation item as compared with statin administration alone for patients who have CAD and received PCI. Also, change of plaque properties is compared with baseline and evaluated. This study is a single-center, randomized, open-label study, using alirocumab, rosuvastatin as test drugs. Based on the findings obtained in this study, it is possible to clarify the mechanism of stabilization of the plaque in a patient with coronary artery disease, which in turn suppresses the progress of plaque in coronary artery disease, resulting in primary or secondary There is a possibility that it can contribute to prevention.

CYPRESS: A Prospective,Randomized,Multi-Center,Double-Blind Trial to Assess the Effectiveness and Safety of Different Durations of Dual Anti-Platelet Therapy (DAPT) in Subjects Undergoing Percutaneous Coronary Intervention with the CYPHER® Sirolimus-eluting Coronary Stent (CYPHER® Stent)

This study is to compare the clinical effect of CYPHER® stent and ENDEAVOR® stent in patients with acute ST elevation myocardial infarction. It also aims to analyze the current status of emergency PCI green channel (time taken from door→ hospital→ PIC sign-off→ needle→ balloon) for patients with ST elevation myocardial infarction in China.

To demonstrate the safety and efficacy of the Cobra Cobalt Super Alloy Balloon-Expandable Coronary Stent System for the treatment of de novo and restenotic (previously unstented) lesions in native coronary arteries in subjects with coronary artery disease (CAD) having a reference vessel diameter (RVD) between 2.5 - 4.0 mm and a lesion length ≤ 26 mm amenable to percutaneous coronary intervention (PCI) with a single stent in subjects with symptomatic ischemic heart disease.

The purpose of this study is to determine whether a 6 month duration of clopidogrel therapy after DES implantation is not inferior to that of a 12 month therapy.

Standard care for patients with diabetes having CABG surgery at Providence St. Vincent Medical Center includes strict control of blood sugar (glucose) levels for 3 days after surgery. This is done through frequent monitoring of blood sugar levels and by giving insulin continuously through a needle into a vein (intravenously). This intensive glucose control has resulted in fewer complications such as serious infections and death, and has shortened the length of the hospital stay for patients. This study treatment is different from standard treatment in that it extends the intensive glucose control beyond the third postoperative day to one full year. Once discharged from the hospital following the CABG procedure, the intense glucose control is done using subcutaneous insulin (a shot under the skin), oral medications, and by measuring blood sugar levels frequently. The purpose of this study is to see how safe and effective strict glucose control is when extended beyond 3 days and hospital discharge for one year. Another purpose is to see how well patients can comply with the daily management of intensive glucose control for one-year as well as the study follow-up schedule.

Objectives : To evaluate the clinical efficacy, angiographic outcomes, and safety of the new paclitaxel-eluting coronary stent (CoroflexTM Please, B Braun, Germany), compared with another paclitaxel-eluting coronary stent system (TaxusTM, Boston Scientific, USA) in the treatment of coronary stenosis. Study Design : Prospective, open label, 2: 1 randomized multi-center trial. Patients will be randomized according to the type of drug eluting stent ( CoroflexTM Please vs. TaxusTM). Randomization will also be stratified per hospital for the presence of DM and the presence of long lesions (lesion length > 28mm) Patient Enrollment :915 patients enrolled at 13 centers in Korea. Patient Follow-Up :Clinical follow-up will occur at 1, 4, 9, 12 months and 2, 3years after intervention. Investigator or designee may conduct follow-up as telephone contacts or office visits. Primary Endpoint :Clinically driven Target vessel Revascularization (TVR) at 9 months. Secondary Endpoints :A. Clinical safety and efficacy end points Major Cardiac Adverse Events (MACE; All Death, cardiac death, Myocardial infarction (Q-wave and non-Q wave), TVR) Target Vessel Failure (TVF; cardiovascular death, myocardial infarction, clinically driven TVR) Stent thrombosis B. Angiographic efficacy end points in-stent binary restenosis by QCA in-stent and in-lesion late loss by QCA in-stent and in-lesion MLD and percentage diameter stenosis by QCA immediately after the index procedure and at 9 months of follow-up

Objectives To evaluate the safety and long-term effectiveness of coronary stenting with the Everolimus-eluting coronary stent system(EECSS) (XIENCETM V, Abbott Vascular, Santa Clara, CA, PromusTM, Boston Scientific, Natick, MA), compared with the sirolimus-eluting coronary stent system(SECSS) (CypherTM, Cordis Johnson & Johnson, Warren, NJ) in the treatment of coronary stenosis. To evaluate the safety and efficacy of 6-month clopidogrel therapy compared with 12-month clopidogrel therapy. Study Design: Prospective, open label, two-arm, randomized multi-center trial to test the non-inferiority of EECSS compared with the SECSS, and to test the non-inferiority of 6 months duration compared with 12 months duration of clopidogrel therapy. Patients will be randomized in a two by two factorial manner according to the type of drug eluting stent (EECSS vs. SECSS) and the duration of dual anti-platelet therapy (6 months vs. 12 months). Randomization will also be stratified per hospital for the presence of DM and the presence of long lesions (lesion length ≥ 28mm) Patient Enrollment: 1,372 patients enrolled at 17 centers in Korea. Patient Follow-Up: Clinical follow-up will occur at 1, 3, and 9 months, and at 1, 2, 3, 4, and 5 years. Investigator or designee may conduct follow-up as telephone contacts or office visits. Primary Endpoint In-segment late luminal loss (LL) at 9 months for comparison of stenting with EECSS vs. SECSS. Target vessel failure (TVF) (cardiac death, myocardial infarction, ischemia driven target vessel revascularization) at 12 months for comparison of 6 months vs. 12 months of clopidogrel therapy Secondary Endpoint All Death Cardiac death Myocardial infarction Target vessel revascularization (TVR) (all and ischemia-driven) Target lesion revascularization (TLR) (all and ischemia-driven) Stent thrombosis Acute success (device, lesion, and procedure) Bleeding Cerebrovascular accident In-stent LL at 9 months Angiographic pattern of restenosis at 9-month angiographic follow-up In-stent and in-segment % diameter stenosis (%DS) at 9 months In-stent % volume obstruction (%VO) at 9 months Incomplete stent apposition post index procedure Persisting incomplete stent apposition, late-acquired incomplete stent apposition, aneurysm, thrombosis, and persisting dissection at 9 months

The purpose of this study is to examine the effects of tirofiban on platelet function the Ultegra RPFA in diabetic patients undergoing elective coronary angioplasty and stenting already treated with high loading dose (600mg) clopidogrel. About 44 people will be in the study. The study duration is a single hospitalization period during which the angioplasty will be performed in addition to a 30-day post hospitalization follow-up period. Patients taking part in the study will be assigned by chance into two groups. Group 1: patients will be treated with the glycoprotein inhibitor, Tirofiban (25mcg/kg over 3 min bolus dose and 0.15 mcg/kg/hr for 12-24 hours), started immediately after insertion of the sheath. Group 2: patients will be treated with equivalent placebo All patients will be loaded with 600 mg clopidogrel at least 4 hours prior to scheduled intervention. All patients will have platelet function analyses at baseline and following treatment.

This is a prospective double blind trial of intraoperative transmyocardial bone marrow-derived mesenchymal cell transplantation vs placebo in patients with low left ventricular ejection fraction scheduled to coronary bypass operation.