A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for...
AtherosclerosisHeart Diseases3 moreEVOLVE 4.5/5.0 is a prospective, single-arm, multi-center observational (standard of care) trial intended to confirm the safety and effectiveness of the SYNERGY 4.50 mm and 5.00 mm Coronary Stent System for the treatment of patients with coronary artery disease in large vessels (≤ 28 mm in length, by visual estimate, in native coronary arteries > 4.00 mm to ≤5.00 mm in diameter, by visual estimate). This Post Approval study is a cohort associated with the SYNERGY MEGATRON Post Approval Study, which is registered under ClinicalTrials.gov ID: NCT04807439.
The CHORAL Flow Study
Coronary Artery DiseaseAtherosclerosis1 moreCHORAL Flow is a randomised, double blinded, placebo-controlled trial of the effects of evolocumab on coronary flow at 12 weeks.
A Placebo-Controlled Trial of CLBS16 in Subjects With Coronary Microvascular Dysfunction
Coronary Microvascular DysfunctionCoronary Microvascular Disease1 moreThis clinical trial will explore the efficacy and safety of GCSF-mobilized autologous 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 administration of CLBS16 or placebo.
DEFINing the PrEvalence and Characteristics of Coronary Artery Disease Among Patients With TYPE...
Type 2 Myocardial InfarctionThe primary objectives of this study include: determine the prevalence of coronary artery disease among patients with type 2 myocardial infarction determine the prevalence of hemodynamically significant stenosis among patients with type 2 myocardial infarction The investigators hypothesize that patients with type 2 myocardial infarction will have a high burden of coronary artery plaque and a high prevalence of obstructive coronary artery disease with hemodynamic significance.
Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly...
CardiomyopathyCoronary Artery Disease2 moreThe overall aim of this trial is to study the safety and efficacy of ICD implantation as a primary prevention strategy of sudden cardiac death in patients 70 years and older. This study will assess the many competing factors involved with ICD implantation including 1) the impact on mortality, especially in the context of a declining rate of sudden death with advanced age, 2) the tolerability of the powerful therapeutic action of the device, and 3) the impact on quality of life.
Drug-Eluting Balloon in Stable and Unstable Angina
Coronary Artery DiseaseThe purpose of this study is to compare DEB with BMS in CAD patients who are at high risk of bleeding and in whom the use of DES is therefore avoided. Our hypothesis is that PCI with DEB is non-inferior to BMS in the treatment of stable CAD or in ACS (UAP or NSTEMI) in patients at high risk of bleeding.
The eSVS® Mesh Post-Marketing Trial
Coronary Artery DiseaseMyocardial Ischemia6 moreThe purpose of this study is to evaluate patency rates of the eSVS Mesh Saphenous Vein Graph (SVG) and control SVG at six and twenty-four months via coronary angiography and analyses of Duplex Sonography Results and coronary angiography and major cardiovascular or cerebrovascular event (MACCE)-Rate as well as analysis of preoperative great saphenous vein (GSV) duplex sonography and intra-operative GSV harvesting findings and procedure.
Stem Cell Injection to Treat Heart Damage During Open Heart Surgery
Heart DiseaseIschemic Heart Disease2 moreBackground: - Bone marrow stromal stem cells (also known as mesenchymal stem cells) have been isolated and are found to make large amounts of growth factors. Because they make growth factors, these cells can help re-grow tissue and encourage repair of damaged tissue. Tests on damaged heart muscle suggest that injecting these cells directly into damaged heart muscle can improve heart function. Researchers want to give stem cells to people who are having open heart surgery to see if they can help to repair heart muscle damage. Objectives: - To test the safety and effectiveness of bone marrow stromal stem cell injections given during heart surgery to treat heart muscle damage. Eligibility: - Individuals at least 18 years of age who are scheduled to have open heart surgery for heart artery or vein blockages. Design: Participants will be screened with a physical exam and medical history. Blood and urine samples will also be collected. Participants will have bone marrow taken from both hip bones about 3 weeks before the heart surgery. During the surgery, the stromal stem cells collected from the bone marrow will be given into the damaged portion of the heart muscle. The rest of the heart surgery will be performed according to standard procedures. After the surgery, participants will be monitored for complications from the stromal stem cells. Participants will have heart function tests to see if the stromal stem cell treatments were effective....
Multi-Center Clinical Trial: Evaluation of Effectiveness and Safety
Coronary DiseaseThis trial aims to demonstrate the non-inferiority of the CI-CMS-005 Coronary Stent System to the study device as well as to the TAXUS™ Express2™ Drug-Eluting Coronary Stent System in in-segment late lumen loss at 9 months after treatment of a single de novo lesion per vessel.
SPIRIT Small Vessel Registry
Coronary Artery DiseaseAtherosclerosis1 moreTo evaluate the safety and effectiveness of the 2.25 mm XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS) in improving coronary luminal diameter in subjects with ischemic heart disease due to a maximum of two de novo native coronary artery lesions in small vessels, each in a different epicardial vessel.