Acolyte CTO-PCI Study: Imaging and Catheter System to Treat Patients With Coronary Chronic Total … (NCT06795763) | Clinical Trial Compass
By InvitationNot Applicable
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
United States115 participantsStarted 2025-08-06
Plain-language summary
This is a study to evaluate the safety and effectiveness of the Acolyte Catheter System used in CTO-PCI procedures. The system will be used for the placement and positioning of guidewires and catheters in the coronary vasculature for the treatment of patients with coronary chronic total occlusions with persistent symptoms following medical therapy.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Subject has history of allergy to iodinated contrast that cannot be managed medically
* 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
* Atherectomy procedure is planned for the target lesion
* 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
* 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…
What they're measuring
1
Procedure Success - Visualization of Guidewire
Timeframe: From the beginning of the study procedure to the end of the study procedure
2
Procedure Success - Absence of Major Adverse Cardiac Events
Timeframe: From the beginning of the study procedure until discharge or 24 hours after the procedure (whichever comes first)