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590 active trials for Coronary (Artery) Disease

The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary Arteries

The objective of this study is to verify the safety and efficacy of the investigational device (ELX1805J) for the treatment of ischemic heart disease due to de novo, native coronary artery lesions

Start: December 2020

Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting

Multi-center, prospective, randomized controlled study comparing PCI guided by angiography versus iFR Co-Registration using commercially available Philips pressure guidewires and the SyncVision co-registration system, employing an adaptive design study for interim sample size re-estimation.

Start: May 2021

The Helios Heart Registry: A Standardized Registry for Patients With Specific Cardiac Diseases

Investigator-initiated, prospective, non-randomized, open label, non-interventional multicenter registry to evaluate current treatment of three major cardiovascular disease entities in clinical practice using a standardized variable-set of relevant covariates and outcome measures.

Start: March 2021

Sort Out XI - Combo Stent Versus BioMatrix Alpha Stent

SORT OUT XI Comparison of Combo™ stent and BioMatrix Alpha™ stent in the treatment of unselected patients with ischemic heart disease.

Start: August 2019

Clinical Evaluation of A New High-speed and High-resolution Intravascular Ultrasound System

InSight Lifetech Intravascular Ultrasound Diagnostic System (referred to as InSight Lifetech IVUS system below),is a new high-speed and high-resolution device for providing clear images of plague morphology, as well as the quantitative and qualitative assessment of coronary artery. This study will compare the differences, if any, between the intravascular ultrasound(IVUS) measured by the two different IVUS diagnostic system.

Start: March 2021

Comparative Clinical Study of Drug-coating Balloon Strategy and Drug-eluting Stent Strategy

The trial aims to evaluate the long-term clinical outcome of the DCB-only technique is non-inferior to the provisional T stenting with DES in the patients who have 'true' bifurcation lesions.

Start: June 2021

Protocol in Reeducation Occupational Therapist in Coronary Patients

The quality of life, linked to physical, social and mental performance in people with coronary heart disease represents the primary goals in terms of rehabilitation. This is often developed to meet the expected performance standard in order to give the person effective autonomy. However, is the occupational balance always evaluated? and this management adapted? Does occupational therapist, expert in autonomy and independence in multiple illnesses and disabilities, has a major role to play in cardiac rehabilitation? This area of expertise and the application of occupational therapy to coronary patients seems appropriate, if not necessary. However, there are few scientific studies on the need to include occupational therapy within cardiac rehabilitation protocols.

Start: November 2020

Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions

The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device Exemption pivotal trial, as a condition of the US Food and Drug Administration (FDA) approval (P170030).

Start: January 2020

Incidental Coronary Calcification Quality Improvement Project

This is a multi-center, randomized quality improvement project. At least 200 statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental coronary artery calcium (CAC) on a prior non-gated chest CT will be enrolled across the Stanford Healthcare System and the Palo Alto Veteran's Affairs Healthcare System. Patients will be randomized in a 1:1 fashion to notification or usual care arms. The primary aim of this project is to estimate the increase in 6-month statin prescription among statin-naïve patients without a history of atherosclerotic cardiovascular disease with incidental CAC on a non-gated chest CT who are randomized to receive notification of their findings vs. usual care.

Start: March 2021

Effect of Topical Anesthesia on Hemodynamics During the Induction Period in Patients Undergo Cardiac Surgery.

The aim of the induction is to decrease stress response of endotracheal intubation. It is also important to keep hemodynamics stable during and after the induction period. Previous studies have shown that topical anesthesia can provide excellent superior supraglottic and subglottic local anesthetic effects and can significantly reduce the dosage of intravenous anesthetics. Therefore, it is significant to explore whether the combination of topical anesthesia and intravenous anesthetics could decrease the stress response of endotracheal intubation and keep hemodynamics stable during and after the induction period.

Start: March 2021

A Clinical Trial to Confirm Safety & Effectiveness of the SYNERGY 4.50 mm and 5.00 mm Stent for Treatment of Atherosclerotic Lesion(s)

EVOLVE 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.

Start: May 2019

Multicenter Study Into Individualized Scanning for Coronary Artery Disease

To evaluate intravascular attenuation of the coronary arteries and image quality in an individualized scan and CM injection protocol whereas both scan and injection parameters are tailored to the individual patient in a North American, European and Asian patient population. To evaluate the radiation dose and contrast media dose of this individualized approach for CCTA in an American, European and Chinese patient population. To evaluate the injection parameters required for an average American, European and Chinese patient population.

Start: March 2021

Comparison of Saphenous Vein Harvesting by Endoscopic Versus Open Conventional Methods

The aim of this study is to investigate the histological and immunohistochemical findings of the saphenous vein graft, to rule out endothelial damage as a direct result of manipulation or instrumentation by endoscopic and open conventional harvesting methods. Furthermore, to investigate if there are any differences in the surgical site infection, cardiac event and functional status between the two harvest strategies at 1-year of follow-up.

Start: January 2020

RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)

To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population. To collect data on the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in bifurcated lesions.

Start: May 2018

Ammonia N-13 Myocardial Blood Flow Absolute Quantification by PET in Patients With Known or Suspected CAD (Ammonia MAP)

This study is being conducted to provide access to and collect test data for an established nuclear medicine diagnostic imaging test called Positron Emission Tomography (PET), using a specific radioactive drug called Ammonia N-13 (Ammonia), referred to simply as an Ammonia PET scan, which is used to visualize the blood flow through the blood vessels and into the heart muscle in order to identify areas of restricted blood flow within the heart. The scanner used in this study may be a stand-alone PET scanner or a PET/CT scanner, which combines the PET scanner and a Computed Tomography (CT) scanner into a single device. Unless otherwise stated in this consent form, the term PET will be used to refer to both stand-alone PET and PET/CT scanners. While physicians have used the Ammonia PET test for many years to visualize (image) the blood flow into the heart muscle (perfusion), it is now possible to also measure the flow of blood into the heart muscle. Research studies have demonstrated clinical value in reviewing the measured blood flow values in addition to reviewing the perfusion images of blood flow into the heart muscle. Therefore, this study will establish a database of a large number of Ammonia PET measured blood flow values to serve as a future reference.

Start: September 2020

RESOLUTE ONYX Post-Approval Study

To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.

Start: March 2017

Assessment of Patients With suspeCted Coronary Artery Disease by Coronary calciUm fiRst strATegy vErsus Usual Care Approach.

The cost of medical care in the United States far exceeds that of all other advanced economies and continues to accelerate at a rate unacceptable to our society, due primarily to the high costs of new imaging technologies and novel drugs (1). Cardiac positron emission tomography (PET) imaging is a powerful new modality for the non-invasive detection of provocable coronary ischemia in patients with low to intermediate-risk chest pain or its equivalent. Intermountain Medical Center (IMC) is performing approximately 6000 clinical cardiac PET scans annually. However, cardiac PET scans are expensive (i.e., billed at >$5,000/scan, average receivable revenue $1500-$2000/scan). Coronary artery calcium (CAC) is a sensitive marker of coronary atherosclerosis. A CAC scan (CACS), performed by multislice computed tomography (CT), is a relatively inexpensive (~$70-$150/scan), low-radiation dose test that marks the presence of coronary atherosclerotic plaque. The absence of CAC has been shown to be associated with very low coronary risk. ACCURATE will test whether a CAC-first strategy (i.e., risk stratification, when CAC ? 1, to medical management or to cardiac PET stress testing), performed routinely in symptomatic patients presenting for evaluation of possible coronary artery disease (CAD) prior to the cardiac PET stress test, can be used as a gatekeeper for progression to the expensive rubidium-PET stress (regadenoson) perfusion scan and be a major cost-saver without adversely affecting patient care or outcomes. Routinely, qualifying patients undergo CACS when they present for evaluation of possible but unknown CAD status and are referred for cardiac PET stress testing. In ACCURATE, those with CACS?1 will then be consented and randomized to either a cardiac PET stress test strategy or a non-PET-driven medical care strategy. Subjects randomized to the cardiac PET stress test strategy will receive appropriate subsequent care depending on the outcome of the cardiac PET scan (i.e., depending on whether ischemia is present or not). Subjects randomized to the CAC-only arm will receive appropriate non-PET driven medical clinical management and follow-up. All participating subjects' electronic medical records will be reviewed indefinitely for clinical outcomes. Initial outcomes will be reported at 1-year, 2-years, and 5-years, with future analyses to be determined by the study investigators. The objective of this study is to test the hypothesis that PET stress test strategy will results in a decreasing in major adverse cardiac endpoint without exceeding $100,000 per quality-adjusted life year compared to a CAC-first strategy for screening suspected/possible coronary artery disease.

Start: November 2019

REvascularization and Valve Intervention for Ischemic Valve diseasE: REVIVE Trial

Ischemic mitral regurgitation (MR) and coronary artery disease is common and associated with significant morbidity and mortality. Ischemic MR has been traditionally treated surgically through either valve repair or replacement at the time of concomitant bypass grafting. Although patients with ischemic MR represent a heterogeneous group, outcomes for these patients over the intermediate term is poor owing to left ventricle (LV) dysfunction causing MR and the presence of coronary disease, which portends poor survival. There is an emergence of percutaneous therapies to treat MR which have been shown to be a less invasive, safe, and viable approach to treat comorbid patients. The decision to treat ischemic MR either surgically or percutaneously is influenced by the presence of coronary disease and the ability to provide adequate revascularization. Mitral valve surgery concomitant to surgical revascularization, however, is associated with a several fold increase in mortality. In fact, the incremental risk increase is further magnified in high-risk patients. We therefore propose a novel prospective study to guide intervention for ischemic MR. Patients will be randomized to undergo surgical therapy with either mitral repair/replacement and/or concomitant coronary artery bypass grafting OR percutaneous mitral repair, followed by the ideal Heart Team determined mode of revascularization with either percutaneous coronary intervention or coronary artery bypass grafting.

Start: June 2021

Efficacy and Safety of ZotaRolimus-Eluting Coronary Stent System In Patients With Long Coronary Artery Disease

This study is to evaluation the efficacy and safety of Zotarolimus-Eluting Stent in patients with long coronary artery disease of 25 mm or longer.

Start: December 2017

Epicardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment (The EXACT Trial)

The primary purpose of this trial is to determine the safety of XC001 (AdVEGFXC1) in patients who suffer from angina caused by coronary artery disease and have no other treatment options. Subjects in this study will receive one of four intramyocardial doses of XC001 that expresses human vascular endothelial growth factor (VEGF) which induces therapeutic angiogenesis (revascularization).

Start: January 2020