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Study Title A post market registry of Abluminus® sirolimus eluting coronary stent system for percutaneous intervention in patients with diabetes mellitus Purpose The purpose of this registry is to prospectively capture clinical data of ABLUMINUS® sirolimus eluting stent in patients with Diabetes Mellitus. Investigational Device ABLUMINUS® sirolimus eluting stent consists of four components; a bare metal stent (BMS), a delivery system, the bio absorbable polymer delivery matrix and Abluminal surface coating on stent and parts of balloon in Pre-crimped condition the anti-proliferative drug, Sirolimus. Study Design Prospective, Observational, Multi‐center registry Estimated Enrolment 1000 patients End points Primary Endpoints: Target Lesion Failure that is composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target lesion revascularisation within 12 months. Components of the primary end point are defined as follows: - Cardiac Death: any death due to immediate cardiac cause, deaths related to the procedure, unwitnessed death, and death of unknown cause. - Target Vessel Myocardial infarction: categorised according to the Minnesota electrocardiographic criteria (Q-wave and non-Q-wave). Spontaneous myocardial infarction was defined as a typical rise and fall of creatinine kinase-MB fraction or troponin in the presence of at least one of several conditions: ischaemic symptoms, new pathological Q waves, ischaemic electrocardiographic changes, or pathological evidence of acute myocardial infarction. Peri-procedural myocardial infarction was defined as an increase in creatinine kinase to more than twice the normal value with increased values of confirmatory biomarkers (creatinine kinase-MB fraction or troponin higher than usual). Target-vessel-related myocardial infarction was one related to the target vessel or that could not be clearly related to another vessel. - Target Lesion Revascularisation: any repeat percutaneous or surgical intervention due to a stenosis or occlusion within the device of the index procedure. Secondary Endpoints - Stent thrombosis [Time Frame: 1 month, 12 months, yearly]. Definite and probable stent thrombosis according to ARC definitions; - Cardiac death [Time Frame: 1 month, 12 months, yearly] - Target Vessel Myocardial infarction [Time Frame: 1 month, 12 months, yearly] - Target Lesion Revascularisation [Time Frame: 1 month, 12 months, yearly] - Device Success at 24 hours - Lesion Success at 24 hours - Procedural Success at 24 hours Eligibility Eligible Age: 18 Years and older. Eligible Genders: Both. Inclusion Criteria - The patient must be at least 18 years of age. - Diabetic patient having clinical evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia or positive functional study; acute coronary syndromes will be considered). - The patient is an acceptable candidate for percutaneous trans-luminal coronary angioplasty (PTCA) stenting and emergent coronary artery bypass graft (CABG) surgery. - Culprit de novo lesion in a native coronary artery with significant stenosis (>50% by visual estimate) eligible for stent implantation (no limitation on the number of treated lesions, vessel and lesion length); - Patients included are those for whom the physician has already considered worthwhile the use of Abluminus Stent according to the indications provided by the IFU; - Patient provides written informed consent; - Patient agrees to all required follow-up procedures and visits. Exclusion Criteria • The patient has a known hypersensitivity or contraindication to any of the following medications:Heparin, Aspirin, Both Clopidogrel and TIclopidine, Sirolimus, paclitaxel, ABT 578Stainless steel, Cobalt, biodegradable PLLA polymer. - Patients with hypersensitivity to contrast media who cannot be treated with adequate prophylaxis. - Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrolment into this study. - Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. - History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions - Previous coronary intervention on target vessel. - Non-cardiac co-morbid conditions with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment). - Lesions not allowing a complete balloon inflation or stent deployment. Clinical Follow up At Discharge, 1 month, 6 months, 12 months, yearly.
This clinical trial will explore the safety and effect of GCSF-mobilized autologous ex vivo selected CD34 cells for the treatment of CMD in adults currently experiencing angina and with no obstructive coronary artery disease. Eligible subjects will receive a single intracoronary infusion of CLBS14.
The objective of this clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent implantation strategy in achieving larger post-PCI lumen dimensions and improving clinical cardiovascular outcomes in patients with high-risk clinical characteristics and/or with high-risk angiographic lesions.
The objective of this study is to evaluate the long-term efficacy and safety of coronary stenting with the various types of drug-eluting stents (DES) and to determine clinical device and procedural success during commercial use of DES in the real world. The investigators will compare EES (Xience V/Promus and Xience Prime), SES (Cypher), ZES (Resolute Integrity, Endeavor Resolute, Endeavor), and BES (Biomatrix, Biomatrix Flex, and Nobori).
Participants had randomly divided into two equal groups. Group (A) had received a program of high intensity interval training 30-40 minutes three times per week for one month. The participant will start cycling slowly for five minute without resistance at the beginning of the exercise as warming up, then the active phase will last 20-30 minutes, then decrease the speed with no resistance at the end of the exercise as cooling down. Group (B) will receive a program of inspiratory muscle training by using the threshold based inspiratory muscle trainer for 10-15 minute daily with frequency three times per week for four weeks.
This project aims to assess coronary vessel response to isometric handgrip exercise (IHE) during magnetic resonance imaging (MRI) in children with T1D children and healthy controls. The investigators will compare the groups in terms of surrogate markers of intima media alteration and arterial stiffness, i.e. carotid intima media thickness (CIMT) and aortic pulse wave velocity (PWV).
The aim is to examine the expression of αvβ3 integrin using a novel selective radiotracer in patients with chronich ischemic heart disease and investigate if it is a suitable tool for predicting myocardial recovery and thus prognosis after intervention.
The objective of this study is to evaluate the effect of multiple doses of vericiguat on the QTc interval in patients with stable CAD (coronary artery disease).
This study proposes to develop an MRI technique named Coronary Atherosclerosis T1-weighed Characterization (CATCH) that will improve the quality and reliability of coronary atherosclerosis evaluation, as well as simplify the scanning process and significantly shorten imaging time compared with conventional imaging methods.
This is a prospective study which aims to explore the effect of Trimetazidine on the improvement of coronary microvascular dysfunction in patients with INOCA (ischemia and no obstructive coronary artery disease). Enrolled patients will be assessed SAQ(Seattle Angina Score), Canadian Angina Grade(Canadian Cardiovascular Society, CCS), Six-Minute Walk Test, CFR(coronary flow reserve) .CFR inspection with D-SPECT and pressure guide wire.Patients will receive six months Trimetazidine(20mg tid) after enrollment. And their SAQ (Seattle Angina Score), Canadian Angina Grade(Canadian Cardiovascular Society, CCS), Six-Minute Walk Test, CFR will be followed up.