View clinical trials related to Coronary Stenosis.
Filter by:The presence of inducible myocardial ischemia is considered as the prerequisite for the clinical benefit of coronary revascularization. In this regard, the introduction of invasive pressure-derived physiological indices to guide myocardial revascularization represented a major breakthrough for the treatment of patients with coronary artery disease (CAD), by moving the focus of coronary revascularization from anatomy to physiology . The main premise of coronary physiology is to permit determination of the functional significance of individual stenoses on a per-vessel basis, measurable at the time of clinical decision-making process, thus providing an objective marker to identify ischemic lesions, and therefore patients, most likely to benefit from coronary revascularization . Fractional flow reserve (FFR) is the most widely used pressure-derived invasive physiological index for coronary lesion assessment in contemporary clinical practice. FFR is calculated as the ratio of the mean distal coronary pressure (Pd) to the mean proximal coronary pressure (Pa) across a stenosis during maximal hyperaemia, a condition that is commonly achieved by the intracoronary or intravenous administration of a potent vasodilator agent, such as adenosine. Based on the results of landmark clinical trials, most recent guidelines recommend the use of FFR to identify hemodynamically significant coronary lesions in patients with stable CAD. Despite this, the worldwide adoption of FFR into current clinical practice remains limited , accounting for only 9.8% of coronary procedures in Switzerland . Potential reasons for the low adoption rate of coronary physiology include technical challenges and time consumption related to FFR measurements, inadequate or lack of reimbursement, physician preferences, patient-related discomfort, contraindications and costs associated with adenosine, or in certain countries, no availability of adenosine. The low use of FFR in clinical practice provided a rationale for the development of new invasive physiology indices. By negating the need for administration of pharmacologic agents such as adenosine, saving time, and reducing costs and side effects, hyperaemia-free pressure-derived physiological indices were developed to increase adoption of physiology-guided coronary revascularization into routine clinical practice.
LEMON aim is to evaluate the feasibility, efficiency and security of a standardized Optical Coherence Tomography (OCT) - guided protocol for completion and optimization of Left Main (LM) Percutaneous Coronary Intervention (PCI).
The purpose is to observe and evaluate the safety and efficacy of Bingo drug-coated balloon in the real world.
In patients with chronic stable coronary artery disease (CAD), percutaneous coronary intervention (PCI) targets hemodynamically significant coronary lesions, i.e., those thought to cause inducible ischemia. The hemodynamic severity of a coronary stenosis increases with its tightness and with the myocardial mass of viable myocardium downstream of the stenosis. Compared to the traditional anatomic angiographic approach, assessment of functional relevance by fractional flow reserve (FFR) during coronary angiography has been suggested to improve patient outcomes. Fractional flow reserve (FFR) is based on determination of the coronary perfusion pressure downstream of a stenosis during pharmacologic hyperemia. However, FFR relies on oversimplified physiologic concepts, which limits its usefulness in defining a true ischemic threshold. Furthermore, visual angiographic assessment continues to dominate the treatment decisions for intermediate coronary lesions. Conversely, the intracoronary ECG (icECG) provides an inexpensive, sensitive and direct measure of myocardial ischemia. The icECG is easily acquired by attaching a reusable alligator clamp to a conventional angioplasty guidewire (at one tenth the price of a pressure sensor guidewire). The coronary guide wire positioned downstream of a coronary stenosis then acts as the exploring electrode. During pharmacologic stress, the icECG can provide direct evidence for regional myocardial ischemia to define the ischemic threshold in different types of coronary artery disease.
The study will enroll approximately 316 subjects with a wide spectrum of PCI indications (stable angina as well as ACS), who are considered to be at high risk of bleeding. Patients will undergo PCI with implantation of the EluNIR stent, followed by shortened duration (1 months in stable patients, and up to 3 months in ACS patients) of DAPT.
The Philips Angio-iFR medical software device is intended to provide information on the functional significance of a coronary artery lesion to provide guidance on diagnostic decisions similar to that obtained through invasive measures of iFR and FFR. The software application uses the vessel geometry obtained from a coronary angiographic image together with a lumped parameter physiological model to provide the associated iFR and FFR estimates.
The primary objective of this study is to assess the accuracy, efficacy, and durability of the OpSens Medical OptoWire Deux pressure wire in the assessment of angiographically intermediate proximal left anterior descending coronary artery (LAD) stenoses in clinical practice.
The goal of the ACCURACY study is to assess the differences, if any, in FFR measurements made by the OptoWire Deux FFR guidewire by comparison of simultaneous data of two different OptoWire DeuxTM guidewires (group 1). In addition, the investigators will compare (group 2) the FFR measurements obtained from an OptoWire Deux FFR guidewire and compare it to the FFR measurement by a VERRATA-TM guidewire to assess coronary stenosis in the routine clinical practice.
The aim of GEOMETRY study is to investigate the correlation between coronary plaque geometric modifications and lesion vulnerability in patients with suspected coronary artery disease referred for cardiac computed tomography angiography (CCTA). Furthermore the study will evaluate the impact of plaque eccentricity and morphology on the rate of major adverse cardiovascular events (MACE) for a 2 years follow-up period.
This is a prospective, multi-center, single-arm, open-label clinical trial. Clinical follow-up will be performed at 30 days. Follow-up by phone will be performed at 6 months, and 1 year after the procedure. Study Objective is to further assess the safety and efficacy of long (38 mm) Ridaforolimus Eluting Stent - EluNIR.