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

Enrolling by invitation · Not applicable

Conditions studied: Coronary Chronic Total Occlusions, Ischemic Heart Disease, Ischemic Heart Disease (IHD), Ischemic Heart Disease Chronic

In brief

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.

Key facts

Study ID: NCT06795763
Run by: Elumn8 Medical
People needed: 115
Starts: 2025-08-06
Expected to finish: 2027-09-01
Last updated by the study team: 2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 of the Investigator, put the patient at risk or confound the results of the study
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

Where it is running

Piedmont Heart Institute — Atlanta, Georgia, United States
Emory University Hospital — Atlanta, Georgia, United States
Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
St. Francis Hospital — Roslyn, New York, United States
PharmaTex Research — Amarillo, Texas, United States

Full record on ClinicalTrials.gov

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