View clinical trials related to de Novo Coronary Lesions.
Filter by:Drug-coated balloon (DCB), as an implant-free treatment technique, has been widely used in coronary interventional therapy, effectively solving the problem of restenosis caused by traditional stent implantation, and providing a treatment option for patients with coronary heart disease with high blood risk. However, in DCB treatment of coronary artery lesions, the incidence of dissection is as high as 10-20% when the balloon is predilated, which often requires salvage stent implantation, resulting in the treatment failure of DCB and bringing great hidden dangers to patients. The main reason was that excessive balloon predilation was caused by the standard of vascular anatomy (residual lumen stenosis less than 30%). The resting full cycle ratio (RFR) is a reliable method for determining the presence of functional ischemia in coronary artery lesions and enables immediate detection. We hypothesized that RFR-guided stepped-balloon dilation could reduce the incidence of dissection and increase the success rate of DCB treatment. Fifty patients who planned to receive DCB treatment were randomly divided into balloon dilation alone (n=25) and RFR-guided stepped-balloon dilation group (n=25). The primary endpoint was the success rate of DCB treatment. This study will provide a functional evaluation based balloon predilation method for DCB treatment, making DCB treatment for orthotopic coronary artery disease more safe and effective.
The TAXUS ARRIVE 2 study is a multi-center safety and surveillance study designed to to compile safety surveillance and clinical outcomes data for the TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System in routine clinical practice and to identify low frequency TAXUS related clinical events.