Active clinical trials for "Coronary Stenosis"

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

The overall aim is to build an AI driven national Platform for CT cOronary angiography for clinicaL and industriaL applicatiOns (APOLLO) for automated anonymization, reporting, Agatston scoring and plaque quantification in CAD. It is a "one-stop" platform spanning diagnosis to clinical management and prognosis, and aid in predicting pharmacotherapy response.

The management of patients with unprotected left main coronary artery (LMCA) disease undergoing percutaneous coronary intervention (PCI) in contemporary interventional cardiology practice remains matter of intense debate. Particularly, the combination of the optimal drug-eluting stent (DES) selection and antiplatelet regimen for patients who require LMCA PCI remains undetermined. Newest-generation thin-strut polymer-free drug-coated stents have the potential to further mitigate chronic inflammation and promote faster re-endothelialization. In the LEADERS FREE randomized trial, PCI with the early-generation BioFreedom (Biosensors International, Switzerland) thick-strut stainless-steel drug-coated stent group was associated with significantly lower rates of the primary safety endpoint, defined as a composite of cardiac death, myocardial infarction, or stent thrombosis at 12 months compared to bare-metal stents among 2,466 patients at high-risk of bleeding who received one-month dual antiplatelet therapy (DAPT), a difference driven by a significantly lower risk for clinically driven target-lesion revascularization. In the ONE-MONTH DAPT randomized study, which enrolled 3,020 patients with coronary artery disease considered for PCI for noncomplex lesions, the rates of the primary composite endpoint of cardiac death, nonfatal myocardial infarction, target vessel revascularization, stroke, or major bleeding within 12 months occurred similarly in patients treated with 1-month DAPT after PCI with early-generation thick-strut stainless-steel polymer-free drug-coated stent (BioFreedom, Biosensors International, Switzerland) and those treated with 6- to 12-month DAPT after newer-generation biodegradable polymer DES (Biomatrix, Biosensors International, Switzerland or Ultimaster, Terumo Corp., Japan) implantation. However, no dedicated randomized clinical trial to date has evaluated the safety and efficacy of newest-generation thinner-strut cobalt-chromium polymer-free drug-coated stents combined with a P2Y12 inhibitor-based SAPT strategy among patients undergoing highly complex PCI procedures, such as those treated for LMCA disease. Recent evidence from a large-scale meta-analysis of several randomized clinical trials including >32'000 patients indicated that 1-3 months of DAPT followed by P2Y12 inhibitor single antiplatelet therapy (SAPT) after second-generation DES implantation was associated with lower risk for major bleeding and similar risk for adverse ischemic outcomes compared with conventional DAPT. These findings suggest that P2Y12 inhibitor SAPT following a short DAPT course (1-3 months) may represent a valuable treatment option for patients undergoing PCI with newer-generation DES compared to standard conventional 12 months DAPT, but this strategy has never been investigated in dedicated randomized clinical trials focused on patients at highest-risk for ischaemic events, such as patients undergoing LMCA PCI. The ULTRA-LM randomized trial aims at filling this current gap of knowledge, which may have large impact on clinical practice and international guidelines. ULTRA-LM will be the first randomized clinical trial to investigate the safety and efficacy of a novel thin-strut cobalt-chromium BioFreedom Ultra polymer-free drug-coated stent (Biosensors International, Switzerland) combined with P2Y12 inhibitor-based single antiplatelet therapy among patients undergoing PCI for LMCA disease.

Prospective, randomised, open-label, international multicenter trial to evaluate the safety and efficacy of drug-coated balloon (DCB) treatment compared to drug-eluting stenting (DES) in patients with large coronary artery disease.

The Century Trial is a single center Phase III randomized study sponsored by the Albert Weatherhead III Foundation and conducted by Dr. K. Lance Gould. The study hypothesis is that a combined image-treatment regimen of PET + comprehensive program of lifestyle modification and lipid lowering drugs to target lipid level will result in an improved cardiovascular risk score when compared to current standard optimal medical therapy, potentially resulting in a lower rate of death, non-fatal myocardial infarction (MI) and revascularization procedures during long term follow-up when compared with current standard of care. If our hypothesis is correct, we will not only improve our ability to prevent and treat CAD but we will also illustrate that, even with the expenses of behavioral interventions and imaging techniques, we can be very cost effective. This information may help patients at risk or with known CAD to obtain insurance coverage to prevent the disease as well as providing a more effective way of treating it.

To establish if the cardiac radiation dose assesment is well aproximated with routine 3D CT scan compared to 4D CT experimental scan with respiratory gating (breath motion monitoring). The study population relates to left side breast cancers female patients that require a radiation therapy treatment.

The Reverse T-stenting And Minimal Protrusion (Reverse TAP) is an up-front 2-stent technique that treats complex coronary bifurcation. Compared to crush techniques, it does not require crushing of the side branch stent but only minimal protrusion of the side branch stent before main vessel stenting. Nowadays, no studies compare the Reverse-TAP and the External Minicrush in treating complex coronary bifurcation, so eventually, procedural, clinical and safety differences remain unknown.

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.

Patients with chronic coronary syndromes (CCS) diagnosed without significant lesions in invasive coronary angiography (ischemia non-obstructive coronary artery disease - INOCA) represent approximately 50% of all patients with CCS. Results of FAME study clearly showed that evaluation of coronary circulation should not be accomplished only with visual assessment in resting conditions. Current European Society of Cardiology Guidelines of diagnosis and treatment of CCS published in 2019 emphasize the necessity of performing complex coronary physiology assessment. Invasive physiological measurements and vasoreactivity provocative tests emerged as key tools to differentiate between vasospastic angina, microcirculatory angina, overlap of both conditions or non-cardiac disease. According to contemporary literature, identification of heterogeneity of patients with INOCA is crucial for determination of adequate treatment. An appropriate pharmacotherapy has a potential to improve outcomes including grade of angina, quality of life, exertional tolerance and most important - MACCE (major adverse cardiac and cardiovascular events) free survival. However, there is a lack of evidence on each of the subtypes of INOCA especially in those with signs and symptoms of vasospasm in provocative test but without visual spasm in epicardial vessels.

With the emergence of advanced technology to date in the artificial intelligence (AI), computer aided diagnosis has gradually gained its popularity in the field of healthcare. Particularly, in the clinical practice of coronary artery disease diagnosis, the application of AI could be of great implication in alleviating the shortage of medical sources. To evaluate the effectiveness and safety of the AI-based coronary CT angiographic analysis software (RuiXin-CoronaryAI) for diagnosis of coronary artery stenosis, a retrospective, multi-center, cross-over designed, blinded, sensitivity superiority and specificity non-inferiority clinical trial will be conducted.