Active clinical trials for "Coronary Stenosis"

Recent studies have shown that the systemic inflammation caused by periodontal disease (PD) can determine important changes in the coronary arteries, favoring atherosclerosis progression and development of acute coronary syndromes (ACS). The aim of ATHERODENT study is to assess the interrelation between PD, inflammation and progression of coronary atherosclerosis in patients with ACS. Material and methods: This case-control observational study will enroll 100 patients (group 1 - ACS and associated PD, and group 2 -ACS and no PD), in whom the following data will be collected: (1) demographic and clinical data, (2) cardiovascular risk factors, (3) full characterization of PD markers, (4) systemic inflammatory biomarkers, (5) imaging biomarkers derived from transthoracic echocardiography, computed tomography, coronary angiography, optical coherence tomography and intravascular ultrasound, and (6) assessment of the presence of specific oral bacteria in samples of coronary plaques collected by coronary atherectomy, which will be performed during percutaneous revascularization interventions, when indicated in selected cases, in the atherectomy sub-study. The follow-up will be performed at 1, 3, 6, 12, 15, 18 and 24 months. The primary endpoint of the study will be represented by the rate of major adverse cardiovascular events (MACE rates) in PD vs non-PD patients and in correlation with: (1) the level of systemic inflammation triggered by PD and/or by ACS at baseline; (2) the vulnerability degree of atheromatous plaques in the coronary tree (culprit and non-culprit lesions); and (3) the presence and burden of oral bacteria in atheromatous plaques. Secondary endpoints will be represented by: (1) the rate of progression of vulnerability degree of non-culprit coronary plaques; (2) the rate of progression of atheromatous burden and calcium scoring of the coronary tree; and (3) the rate of occurrence of left ventricular remodeling and postinfarction heart failure.

This study is designed as a prospective observational feasibility study. The investigators will study whether vulnerable plaques on OCT (fibrous cap ≤ 70 μm) show a locally increased uptake of 18F-choline on PET-MRI compared to stable plaques and whether the culprit plaque shows a locally increased uptake of 18F-choline on PET-MRI compared to non-culprit plaques. First, 15 NSTEMI or STEMI patients who underwent urgent percutaneous coronary intervention (PCI) of the culprit vessel, who are diagnosed with multivessel coronary disease and are currently scheduled for a second PCI at the VieCuri hospital will be included. These patients will be subjected to an additional 18F-choline PET-MRI examination at the MUMC+ and an additional optical coherence tomography (OCT) examination (during the PCI procedure at the Viecuri hospital). OCT will be performed as a reference standard to validate 18F-choline PET-MRI for detection of vulnerable plaques in the coronary arteries. In addition, 15 NSTEMI patients, who are scheduled for PCI of the culprit lesion at the MUMC+, will be subjected to an additional 18F-choline PET-MRI examination at the MUMC+. Hereby, the culprit coronary vessel and thereby the culprit plaque can be identified by the location of the myocardial infarct, as identified by late enhanced MRI. The investigators will study whether the culprit plaque shows an increased 18F-choline uptake on 18F-choline PET-MRI compared to non-culprit plaques in the other coronary arteries. All patients will receive standard, guideline-based clinical care, while PET-MRI and OCT will be performed as additional measurements. Before the start of the study, 5 stable angina pectoris patients that are scheduled for a PCI procedure at the MUMC+ will be included at the MUMC+ for a single PET-MRI scan to optimize the parameters of the coronary PET-MRI scan.

The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and safety for reevaluation.

This is a prospective, observational, single-arm, open-label, multicenter, postapproval registry study in China. The purpose of this study is to: Evaluate the continued safety and effectiveness of the XIENCE V EECSS in a cohort of real-world patients receiving the XIENCE V EECSS during commercial use Evaluate patient compliance to dual antiplatelet therapy (DAPT)

The purpose of this Post market Study is to collect clinical data of the Arthesys PTCA catheters family during angioplasty intervention of coronary vessels or coronary bypass graft stenosis to support MDR submission.

The main aim of this study will evaluate differences in serum levels of tryptase in study population. Will be selected a number of 350 patients hospitalized for coronary heart disease.

Approximately 50% of coronary events occur in previously asymptomatic patients. Thus, the early detection of the individuals at higher risk became an important research target within the current cardiology. The various clinical scores used present a predictive accuracy for ischemic events, evaluated by the ROC curve, which ranges from 0.73 to 0, 79. Therefore, the introduction of new non-invasive techniques for the detection of atherosclerosis aims to allow a more adequate classification of risk. The development of radiological techniques, fundamentally coronary angiotomography of multiple detectors (CAMD) and electron beam computed tomography-EBCT‖, demonstrated that the degree of coronary calcification correlates with endothelial lesion and individual prognosis in the long term. Notably, the calcium score has a weak correlation with the severity of coronary stenosis per se, possibly due to variations in arterial remodeling due to coronary calcification. On the other hand, the CAMD allows the detection of a small magnitude atheromatous disease, not diagnosed clinically, nor by tests provoking ischemia, or even by coronary catheterization. The clinical relevance of the small magnitude atheromatous disease diagnosed by the ACMD and its correlation with plaque vulnerability markers, mainly platelet aggregation, vascular reactivity, and inflammation are still not well determined. This is a case and control study and we will enrolled 90 patients with low and medium risk of cardiovascular event whose cases should present discrete plaques in the CAMD e controls should present none plaque in coronary stenosis

Device: EluNIR Ridaforolimus Eluting Coronary Stent System - (hereafter referred to as EluNIR) 2.25 mm diameter (8 mm, 12 mm, 15 mm, 17 mm, 20 mm, 24 mm, 28 mm and 33 mm length) Objectives: To further assess the safety and efficacy of the small diameter (2.25 mm) Ridaforolimus Eluting Stent - EluNIR. Subject Population: Subjects who underwent PCI for angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), NSTEMI, and recent STEMI (>24 hours from initial presentation and stable) with attempted implantation of a 2.25 mm diameter EluNIR stent. Trial Design and Methods: This is a prospective, multi-center, single-arm, open-label clinical trial. Clinical follow-up for all patients will be performed at 30 days 6 months, and 1 year after the procedure.

The device involved in this trail is a diagnostic software with a Prospective, Multicenter, Self Controlled design. FFRCT diagnostic performance was calculated by CardioSimFFRct Analysis software, and the diagnostic accuracy, sensitivity, specificity, positive predictive value and negative predictive performance of FFRCT for myocardial ischemia were calculated per-patient level and per-vessel level with invasive FFR value as gold standard.

The purpose is to observe and evaluate the safety and efficacy of Bingo drug-coated balloon in the real world.