View clinical trials related to Coronary Stenosis.
Filter by:This study evaluates effectiveness and safety of DESyne X2 in Routine Clinical Practice.
This is a prospective, randomized, controlled, multicenter, open-label study designed to assess whether vFFR is non-inferior to FFR in assessment of intermediate coronary stenosis in terms of the occurrence of MACE during 12 months after randomization.
Drug-eluting stent (DES) has been the primary choice for in suit coronary lesions treatment. In comparison to bare-metal stent (BMS), it evidently decreases the rate of restenosis. However, in recent years in-stent restenosis or thrombogenesis caused by acquired stent malapposition in the late stage or by new in-stent atherosclerotic plaques was oberved, which possibly was associated with chronic inflammation stimulation because of residual intravascular metal or polymer coating. Through being expanded around 30 to 60 seconds, drug-coated balloon (DCB) can ensure adequate paclitaxel enter the artery wall, which can inhibit smooth muscle cells hyperplasia without remaining any foreign body. In recent small sample trials, they showed that sole DCB treatment had a good long-term effect when pre-treating ideal in suit coronary lesions (defined as residual stenosis< 30%, without dissection severer than type C, anterograde flow TIMI III). In PEPCAD I trial, the rate of major adverse cardiovascular events (MACE) was 6.1% in the first 12 months and persistent to 3-year follow up. Small sample prospective observational study from Korea, like Shin, showed that in the in suit coronary lesions with the fractional flow reserve (FFR)>0.85 after percutaneous transluminal coronary angioplasty (PTCA), the FFR kept unchanged in the 9-month follow up after DCB treatment and there was not MACE happened. However, so far randomized controlled trials with large sample to confirm their non-inferiority compared with DES when treating relatively larger in suit coronary lesions are lacked. Meanwhile, a number of doctors worried about acute cardiovascular occlusion and long-term restenosis. In this study, we assume that in the in suit coronary lesions with FFR>0.85 after PTCA pre-treatment, DCB treatment is not inferior to DES treatment regarding to middle- and long-term functional recovery.
This study evaluates the effectiveness and safety rotational atherectomy in routine clinical practice.
This study evaluates long-term outcome of patients diagnosed as acute myocardial infarction and treated with medication, coronary artery bypass surgery and percutaneous coronary intervention in Asan medical center, Korea.
VALIDITY is a prospective, open-label, multicenter, randomized controlled trial （ClinicalTrials.gov number）. The study was designed to evaluate the value of noninvasive anatomic CTA combined with functional CTP for the next clinical decision making and the added prognostic value of CTP beyond CTA.
The objective of this study is to evaluate effectiveness and safety of BIOFREEDOM™ FAMILY stent in the "real world" daily practice as compared with other drug-eluting stents.
Cardiovascular disease remains the leading cause of morbidity and mortality worldwide. Coronary computed tomography angiography (CCTA) and, if indicated, invasively measured fractional flow reserve (FFR) is currently used for ruling out significant coronary artery disease. FFRCT is a novel non-invasive technique in which FFR is derived from CT images, however this method is currently, just like CCTA, lacking specificity. Spectral Detector CT (SDCT) is a novel technique whereby a spectrum of monoenergetic images at different kiloelectron Volt (keV) values (40 to 200 keV) can be reconstructed. By using these monoenergetic images, a decrease in blooming and beam-hardening artifacts could be achieved. In addition, SDCT offers the opportunity to assess myocardial iodine distribution and quantification. When combining these factors, we hypothesize more accurate information will be available about the coronary anatomy, degree of stenosis and FFRCT and thereby contribute to a more accurate way for the detection of hemodynamic significant stenosis. Therefore, the aim of this study is to assess the accuracy of SDCT as a non-invasive way for the detection of hemodynamically significant coronary artery stenosis. Objective: The overall objective of this project is to assess the accuracy of SDCT for the detection of flow limiting stenosis in the coronary arteries using invasive FFR as the standard of reference. Whereby different sub-aims (e.g. improvement of FFRCT) are made to answer the overall objective. The secondary objective is to determine the decrease of calcium blooming of calcifications and beam-hardening artifacts and the improvement of myocardial blood volume quantification on SDCT in comparison with conventional CT.
Coronary fraction flow reserve (FFR), the ratio of the mean coronary pressure distal to a coronary stenosis to the mean aortic pressure during maximal coronary blood flow (hyperemia), defines the hemodynamic significance of coronary artery narrowing. Noninvasive assessment of FFR via a combination of computational fluid dynamics (CFD) and coronary CT angiography CCTA (the so-called FFRCT) has potential. Coronary computed tomographic angiography is a noninvasive test for diagnosis of anatomic coronary stenosis (i.e., narrowing of a blood vessel). A new analytical model of FFR from the general Bernoulli equation (conservation of energy) (FFRB) is simple and has potential. A collaborator group has recently developed a new analytical model to quantify pressure drop, and hence FFR, based on lesion dimensions (i.e., the cross-section area along the lesion and the length of lesion) and coronary flow, with no empirical parameters. The investigators hypothesize that this new model will allow quantification of FFR (FFRB) in a cohort of human patients with intermediate coronary stenosis. The study will compare FFRB with invasive FFR measurements from invasive coronary angiography (ICAG).
Revascularization of borderline coronary stenoses (40-70%) is usually driven by fractional flow reserve (FFR) which expresses the physiological significance of a lesion and tells the operator whether PCI may reduce the rate of adverse events as compared to medical therapy. Coronary stenoses with FFR value < 0.80 are indeed associated with a higher rate of adverse event and requires coronary revascularization whereas lesions with FFR > 0.80 show an excellent prognosis which cannot be improved by coronary stenting. Such a predictive value of FFR is theoretically based only on the degree of myocardial ischemia downstream from a given coronary stenosis: however, also plaque composition may play a crucial role in triggering future events especially in patients affected by acute coronary syndrome. Differences in plaque composition between FFR-positive and FFR negative lesions have never been assessed. Intracoronary Near-InfraRed Spectroscopy (NIRS) identifies lipid rich plaques that can potentially cause acute events. The aim of this study is to compare the lipid content expressed by LCBI (Lipid Core Burden Index) between functionally significant (FFR < 0.80) and non-significant (FFR > 0.80) stenoses in patients undergoing coronary angiography because of stable CAD and non-ST elevation acute coronary syndromes. This is an observational, prospective, multicentric study where we plan to collect 150 coronary lesions.