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

NCT06795763 · tracked via the Priya Life Science USA tracker

Sponsor

Elumn8 Medical

Phase

Not applicable

Started

2025-08-06

Last updated

2026-05-19

Condition(s) studied

Coronary Chronic Total OcclusionsIschemic Heart DiseaseIschemic Heart Disease (IHD)Ischemic Heart Disease Chronic

Investigational drug(s) / intervention(s)

CTO-PCI Procedure with Acolyte Catheter System

CTO-PCI Procedure with Acolyte Catheter System: Acolyte Catheter System is used to facilitate placement and positioning of guidewires and catheters within the coronary vasculature for the treatment of patients with coronary chronic total occlusions with persistent symptoms following medical therapy. The device provides real-time visualization of a coronary chronic total occlusion allowing for guidewire placement in the true lumen of the target vessel and subsequent revascularization.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 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

Primary outcome measure(s)

Procedure Success - Visualization of Guidewire — From the beginning of the study procedure to the end of the study procedure
Procedure success is defined as angiographic visualization of a guidewire facilitated by the Acolyte Catheter System, in a distal position of the CTO in the true lumen of the vessel.
Procedure Success - Absence of Major Adverse Cardiac Events — From the beginning of the study procedure until discharge or 24 hours after the procedure (whichever comes first)
Absence of in-hospital major adverse cardiac events (MACE). MACE is defined as any serious adverse experience that includes cardiac death, target lesion revascularization, or post-procedural myocardial infarction (with CK-MB \>= 10x URL or \>= 5x URL with new pathological Q waves in \>= 2 contiguous leads or new persistent left bundle branch block (LBBB)).

Trial sites (5)

Facility	City	Region
Piedmont Heart Institute	Atlanta	Georgia
Emory University Hospital	Atlanta	Georgia
Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
St. Francis Hospital	Roslyn	New York
PharmaTex Research	Amarillo	Texas

Other trials for the same condition

Evaluation of Treatment Strategies for Severe CaLcIfic Coronary Arteries: Orbital Atherectomy vs. Conventional Angioplasty Technique Prior to Implantation of Drug-Eluting StEnts: The ECLIPSE Trial Active, not recruiting

Distal Evaluation of Functional Performance with Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06795763 on ClinicalTrials.gov ↗ ← All trials in the USA