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NCT07473596
The goal of this clinical trial is to describe the long-term (≥ 3 years) patency of coronary artery stents following chronic total occlusion percutaneous coronary intervention (CTO PCI). The main questions it aims to answer are: * What is the incidence of in-stent restenosis after CTO PCI? * What are patient-, lesion-, and procedure-related factors associated with an increased risk of in-stent restenosis after CTO PCI?
NCT06917378
Coronary chronic total occlusions (CTO) present a significant challenge in the field of interventional cardiology. These complex lesions, characterized by complete blockage of a coronary artery for a prolonged duration, often require specialized techniques and strategies to achieve successful revascularization.
NCT07206082
This will be an investigator-initiated, multicentre, single-arm, open-label, prospective observational study. Patients with indication for PCI and undilatable (non-compliant balloon dilatation \<80% at burst pressure) or uncrossable (not crossable with a "small-profile balloon" with adequate support, according to operator´s discretion) coronary lesions treated with ELCA will be included. Intravascular imaging will be highly recommendable and analysed in a central core-laboratory. Device success, angiographical success, procedural success, clinical success and related complications will be evaluated. Patients will be followed for 1 year after the procedure and clinical events will be recorded.
NCT07114393
Coronary artery disease remains a leading cause of mortality worldwide and is commonly treated with percutaneous coronary intervention (PCI). Typically, PCI is guided by invasive coronary angiography (ICA). However, ICA has inherent limitations in accurately assessing vessel dimensions, calcium burden, circumferential tissue and whether a stent has achieved full expansion. \[1\] Therefore ICA alone is insufficient for guiding stent optimization, especially in complex lesions which are most vulnerable to long-term stent failure. \[2\] To overcome the limitations of ICA, intracoronary imaging can be used to guide and optimize PCI. The advantages of intracoronary imaging include obtaining larger lumen areas, better stent expansion and strut apposition, full lesion stent coverage and identifying stent complications. Multiple randomized studies have shown that these advantages translate into a reduction in major adverse cardiovascular events (MACE) in complex PCI. Consequently, the recommendation for intracoronary imaging has been upgraded in the most recent guidelines. \[3-6\] Despite robust evidence supporting its benefits, intracoronary imaging remains relatively underused in real-world practice and in the Netherlands it is only used in 7% of complex PCI procedures. \[7\] This underutilization may be attributed to several factors, including operator and hospital-dependent issues such as lack of experience, reluctance to spend additional time on intracoronary imaging and concerns about its cost-effectiveness. \[8\] Therefore, initiating an implementation project to incorporate intracoronary imaging into routine use in the catheterization lab during complex PCI would be highly valuable. \[9\] Such a project could make imaging-guided PCI the standard of care in complex PCI. Additionally, it could evaluate the cost-effectiveness of routine intracoronary imaging during complex PCI. For this reason we designed the OPTIMIZE-PCI II, a national registry-based quality improvement project. This project is aimed at implementing a liberal intracoronary imaging-guided strategy for complex PCI across multiple centres in the Netherlands, with data extraction from the Netherlands Heart Registration (NHR) database. The objective of the OPTIMIZE-PCI II is to establish a routine use of intracoronary imaging in complex PCI, to determine if this approach reduces adverse cardiac events in real-world practice, and evaluate its cost-effectiveness.
NCT06655922
This registry will include consecutive patients presenting with at least one chronic total coronary occlusion (CTO) identified via coronary angiography or cardiac computed tomography angiography (CCTA) at our center. Due to the complexity of CTO lesions, both procedural success rates and prognosis improvements are limited. The progression and development of atherosclerotic plaques involve fibroblast activity, contributing to the formation of fibrous caps and calcified nodules through various mechanisms. Myocardial fibrosis within chronically occluded segments is strongly linked to ventricular remodeling and patient prognosis. The activation of cardiac fibroblasts (CFs) is a critical early phase in myocardial fibrosis, playing a key role in fibrotic progression. However, the role of activated CFs in CTO patients has remained unclear, mainly due to the lack of reliable in vivo assessment techniques for detecting CF activation. Recent studies have demonstrated that radionuclide-labeled fibroblast activation protein inhibitor (FAPI) imaging is an effective and reliable technique for detecting both myocardial fibrosis and activated CFs in arterial plaques. Preliminary data suggest that FAPI imaging can characterize plaque composition and assess the extent of myocardial fibrosis in various cardiovascular conditions. However, its potential to predict the ease of CTO recanalization and subsequent clinical outcomes remains to be fully explored. The aim of this prospective cohort study is to evaluate the predictive value of FAPI imaging in patients with at least one untreated CTO. All enrolled patients will undergo baseline assessments prior to intervention, including blood tests, clinical evaluations, and imaging studies. These imaging studies will include myocardial FDG/perfusion imaging, FAPI imaging, and resting perfusion imaging. In selected patients, additional evaluations such as stress myocardial perfusion imaging, magnetic resonance imaging (MRI), and echocardiography will also be performed. For patients undergoing percutaneous coronary intervention (PCI), follow-up assessments will occur at 6 and 12 months. At the 6-month mark, improvements in left ventricular (LV) wall motion will be assessed using resting perfusion imaging. At 12 months, coronary angiography (CAG) will be performed on all patients to evaluate recanalization outcomes. Additionally, myocardial perfusion imaging, magnetic resonance imaging (MRI), and echocardiography may be selectively used to evaluate patients during the 12-month follow-up. 1. To evaluate the ability of FAPI imaging in predicting the difficulty of CTO recanalization. 2. To investigate the role of myocardial FAPI imaging in predicting the improvement of LV wall motion at 6 months, assessed using follow-up single-photon emission computed tomography (SPECT). By comparing FAPI imaging with conventional prognostic assessment methods, this study aims to clarify the utility of FAPI imaging in both predicting the recanalization complexity and in assessing long-term clinical outcomes in CTO patients.
NCT06322914
The investigators conducted a retrospective, single-center observational registry upon which one novel scoring system was formed and evaluated for their accuracy in predicting technical success. The investigators reviewed the clinical and angiographic records of 432 patients with 459 CTO lesions who underwent percutaneous recanalization attempts recruited between January 2012 and November 2023. The investigators aims to develop and validate a novel scoring system for predicting CTO-PCI success.
NCT01435031
A prospective, multi-center, single-arm study to establish the safety and effectiveness of the XIENCE V® Everolimus Eluting Coronary Stent, XIENCE nano™ Everolimus Eluting Coronary Stent, XIENCE PRIME™ LL Everolimus Eluting Coronary Stent, HT PROGRESS and HT PILOT Coronary Guide Wires, and MINI-TREK Coronary Dilatation Catheter in patients undergoing elective percutaneous revascularization of native chronic total coronary occlusions