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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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)