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

Chronic Total Occlusion (CTO) Crossing, Re-entry and Imaging With the Acolyte™ Catheter System in Subjects Undergoing Percutaneous Coronary Interventional (PCI) Procedures

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Ischemic Heart Disease; Ischemic Heart Disease Chronic; Coronary Chronic Total Occlusions; Ischemic Heart Disease (IHD)
• Intervention / Treatment: Device: CTO-PCI Procedure with Acolyte Catheter System

Detailed Description

This is a study to evaluate the safety and effectiveness of the Acolyte™ Catheter System used in CTO-PCI procedures as follows:

• Evaluate angiographic confirmation of guidewire placement beyond the CTO, in the true vessel lumen, in which the investigational device was utilized to facilitate crossing and/or re-entry.
• Evaluate in-hospital major adverse cardiac events (MACE).

Acolyte™ Optical Coherence Tomography (OCT) imaging will be utilized in all cases to inform guidewire advancement in the direction of true lumen. Additionally, Acolyte™ OCT imaging will be used to guide re-entry from the subintimal space to the true lumen.

• Study Type: Interventional
• Enrollment (Estimated): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407
      • Minneapolis Heart Institute Foundation
  • New York
    • Roslyn, New York, United States, 11576
      • St. Francis Hospital
  • Texas
    • Amarillo, Texas, United States, 79106
      • PharmaTex Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CTO-PCI Procedure with Acolyte Catheter System

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Success - Visualization of Guidewire	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.	From the beginning of the study procedure to the end of the study procedure
Procedure Success - Absence of Major Adverse Cardiac Events	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)).	From the beginning of the study procedure until discharge or 24 hours after the procedure (whichever comes first)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful Recanalization	Frequency of successful recanalization defined as angiographic confirmation of crossing the chronic total occlusion and restoring blood flow to the affected area	From the beginning of the study procedure to the end of the study procedure
In-Hospital: Frequency of Major Adverse Cardiac Events (MACE)	Any serious adverse experience that includes cardiac death, target lesion revascularization, or post-procedural myocardial infarction.	From the beginning of the study procedure until discharge or 24 hours after the procedure (whichever comes first)
30-Day: Frequency of Major Adverse Cardiac Events (MACE)	Any serious adverse experience that includes cardiac death, target lesion revascularization, or post-procedural myocardial infarction.	30 Day Follow-up
Safety - Blood Vessel Perforation	Frequency of clinically significant perforation (perforation that results in hemodynamic instability and/or requiring intervention including pericardiocentesis, embolization, prolonged balloon occlusion, stent graft, or comparable therapy).	From the beginning of the study procedure to the end of the study procedure
Procedure: Serious Adverse Events Related to Study Device or Procedure	Frequency of serious adverse events (SAEs) related to the study device or procedure	From the beginning of the study procedure until discharge or 24 hours after the procedure (whichever comes first)
30-Day: Serious Adverse Events Related to Study Device or Procedure	Frequency of serious adverse events (SAEs) related to the study device or procedure	30 Day Follow-up
3-Month: Serious Adverse Events Related to Study Device or Procedure	Frequency of serious adverse events (SAEs) related to the study device or procedure	3-Month Follow-up
Procedure: Non-serious Adverse Events Related to Study Device or Procedure	Frequency of non-serious adverse events related to the study device or procedure	From the beginning of the study procedure until discharge or 24 hours after the procedure (whichever comes first)
30-Day: Non-serious Adverse Events Related to Study Device or Procedure	Frequency of non-serious adverse events related to the study device or procedure	30 Day Follow-up
Procedure: Time for Guidewire to Cross Chronic Total Occlusion (CTO)	Time from initial CTO guidewire entered into guide to guidewire crossing chronic total occlusion	From the beginning of the study procedure to the end of the study procedure
Procedure: Fluoroscopy Time	Total fluoroscopy time during procedure	From the beginning of the study procedure to the end of the study procedure
Procedure: Technical Success	Crossing chronic total occlusion and/or re-entry success	From the beginning of the study procedure to the end of the study procedure
Change from Baseline in Seattle Angina Questionnaire-7 at 30 Days	Change from Baseline in Mean Seattle Angina Questionnaire-7 at 30 Days	Baseline and 30 Days
Change from Baseline in Seattle Angina Questionnaire-7 at 3 Months	Change from Baseline in Mean Seattle Angina Questionnaire-7 at 3 Months	Baseline and 3 Months

Collaborators and Investigators

• Sponsor: Elumn8 Medical

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 28, 2025

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: CTO; CTO-PCI
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia
• Other Study ID Numbers: CP24001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No