Chronic Total Occlusion Percutaneous Coronary Intervention

Brief description of study

PCI is a non-surgical procedure to treat many types of heart issues using thin flexible tubes (catheters), guidewires (wires that are used as a guide for placement of other medical devices), and stents (small structures to prop open the blood vessel). PCI is not experimental and is a common heart procedure. The purpose of this study is to see how the study devices perform during treatment of a CTO in the heart. The study devices are catheters and guidewires which are commercially available, meaning, the Food and Drug Administration (FDA) has cleared their use in other heart procedures. In this study, the same medical devices are considered “investigational” for use in treating CTOs because additional data is needed to determine how these medical devices perform when specifically treating CTOs. The purpose of this study is to collect data to support FDA clearance for the use of these medical devices when treating CTOs.

Clinical Study Identifier: s19-01742 Identifier: NCT03988166

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