Coronary Artery Stenosis

This prospective, multi-center clinical trial evaluates the safety and efficacy of the Coronary Laser Atherectomy System for the pretreatment of coronary artery stenosis. The study consists of two phases: a first-in-human (FIM) phase enrolling 5 subjects in a single center, and a pivotal phase, which is a prospective, multi-center, randomized controlled, non-inferiority trial enrolling 218 subjects across approximately 10 centers in China. Subjects are randomized 1:1 to receive either the investigational laser system or the control Philips CVX300 laser system for lesion pretreatment prior to PCI. The primary endpoint is clinical success, defined as successful PCI with residual stenosis \<30%, TIMI flow grade 3, and no death, myocardial infarction, or target lesion revascularization through 7 days post-procedure. Secondary endpoints include device success, procedural success, MACE, target lesion failure, and target vessel failure at 30 days and 6 months. An OCT sub-study is planned for 40 subjects.

The objective of this study is to evaluate the effectiveness and safety of Coroflex ISAR NEO stents in comparison to other drug-eluting stents (DES) in real-world practice.

The objective of this randomized study was to compare outcomes of imaging-and physiology-guided state-of-the-art percutaneous coronary intervention (PCI) to coronary artery bypass grafting (CABG) in patients with diabetes and three-vessel CAD (not involving left main).

It is a prospective, controlled, single-center, non-randomized, observational study. Two patient groups are planned for inclusion: the first - 200 patients with significant coronary artery stenosis confirmed by coronary angiography (CAG) or multislice computed tomography (MSCT) results; the second - a control group consisting of 200 patients without significant stenosis according to CAG or MSCT data. All study subjects will have a date of coronary artery imaging via CAG or MSCT with assessment of myocardial perfusion. Stress echocardiography tests or fractional flow reserve (FFR) assessment will be conducted as indicated. All patients included in the study will undergo ECG recording within 1 month before or after CAG or MSCT in standard lead I for 1 minute, followed by spectral analysis of the obtained data, which will be stored at the remote monitoring center of Sechenov University without being linked to the personal data of patients. A spectral analysis of the electrocardiogram will be performed using a continuous wavelet transform. The result of this study will be the identification of ECG parameters that correlate with significant coronary artery stenosis.

This is a cohort study to investigate the clinical features, current treatment and clinical outcomes in patients with inflammation-associated non-rapidly-progressive coronary artery disease (INR-CAD).

The present case-control study is designed to investigate the disease characteristics of IR-CAD by comparing the demographics, clinical features, lab results, imaging findings, and prior treatment between 20 patients with IR-CAD and 10 patients with AS-CAD.

This is a self-controlled cohort study to evaluate the efficacy and safety of comprehensive treatment in patients with inflammation-associated rapidly-progressive coronary artery disease (IR-CAD) by comparing the study endpoints before treatment with those after treatment in the same group of patients.

The study will evaluate the performance and safety of RisoR Crest Everolimus Eluting Coronary Stent System. A total of 2000 participants will be included in the study from India and Italy.

The aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between mopphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (OCT) including minimal lumen area, plaque type, presence of thin cap fibroatheroma and a functional index - angiography based vessel fractional flow reserve (vFFR) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.

The purpose of the current study is to assess complete coronary physiology (FFR, RFR, CFR, IMR, and CT-FFR) in TAVI candidates with intermediate coronary artery stenosis before and 6 months after TAVI. This aims to determine how TAVI affects coronary blood flow and coronary microcirculatory function after longer-term follow-up, and how these effects influence FFR and RFR values. In addition, it is aimed to correlate invasive functional testing (FFR and RFR) with non-invasive CT-FFR before and 6 months after TAVI.

The study aims to determine a diagnostic marker for regionally impaired myocardial oxygenation response in patients with suspected coronary artery stenosis.

Ischaemic Heart Disease (IHD) is the worlds leading cause of death. IHD is often caused by a narrowing of the coronary arteries, which prevents blood from flowing to the heart muscle, causing pain and damage to the heart. If an individual has a myocardial infarction (MI), parts of the heart that are damaged cannot be repaired. Therefore, it is important to identify and treat the narrowing of the arteries before an MI occurs. At present there are 2 main methods of identifying narrowing of the arteries. The first is an invasive procedure, the other using a CT scan. Whilst both methods are effective, they entail risk. The invasive procedure can damage the coronary arteries, whilst the CT scan exposes patients to radiation and contrast, which can increase the risk of cancer and allergic reactions. Magnetic Resonance (MR) scanning is an alternative to these methods, but it has been limited in use in the past due, in part, to the high technical knowledge required to obtain images. In addition, there is a degree of subjectivity in the selection of the mid-diastolic rest period, potentially affecting consistency of results. This means it is difficult to use in a day-to-day hospital environment. However, recent technological developments using artificial intelligence mean that images can be acquired in a more automated and consistent fashion. This new scan has yet to be tested in a clinical trial. Therefore, the objective of the clinical study is to test this new scan to determine its efficacy. 230 patients at 5 sites at risk of coronary artery disease, who have been referred for invasive coronary angiography, will undergo both their angiography and the new MR scan. The MR scan will then be compared to CCTA for diagnostic accuracy and image quality. The investigators hypothesise that the new MR scan will have the same diagnostic accuracy as invasive coronary angiography, with no differences in interpretation of the images across the 5 different hospitals. If proven effective, this would demonstrate that MR scanning of the coronary arteries could prove a safe, clinically useful alternative to both CT scanning and invasive assessment of coronary artery narrowing. In addition, if there is no difference across different locations, it would demonstrate that these scans can be performed consistently, facilitating implementation on a healthcare-system wide basis.