Acolyte CTO-PCI Study: Imaging and Catheter System to Treat Patients With Coronary Chronic Total Occlusion, Who Have Persistent Symptoms Following Medical Therapy and Are Undergoing Percutaneous Coronary Interventional Procedures

Korábbi kezelés

• Subject has evidence of acute myocardial infarction (MI) within 72 hours prior to the intended treatment
• Subject has had previous coronary interventional procedure of any kind within 30 days prior to the investigational procedure
• History of stroke or transient ischemic attack within 6 months prior to procedure
• Active peptic ulcer or upper gastrointestinal bleeding within 6 months prior to procedure
• Subject participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with this study's endpoints; or requires coronary angiography, intravascular ultrasound, or other coronary artery imaging procedures

Más betegség

• Subject has history of allergy to iodinated contrast that cannot be managed medically
• History of bleeding diathesis or coagulopathy or refusal of blood transfusions
• Other pathology such as cancer, known mental illness, etc., or other condition which might, in the opinion of the Investigator, put the patient at risk or confound the results of the study

Egyéb

• Atherectomy procedure is planned for the target lesion

• Subject is > 18 years of age at the time of consent
• Subject is on medical therapy and continues to experience clinical symptoms considered suggestive of ischemic heart disease (e.g., chest pain or discomfort, heart failure) or has evidence of myocardial ischemia (e.g., abnormal functional study) attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization
• Female subjects of reproductive potential must have a negative pregnancy test per standard of care for PCI
• Subject is willing and able to provided written informed consent
• Subject is willing to and able to comply with the study protocol requirements including all follow up visits post-procedure