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 | Enrolling By Invitation FDA Device

• 1 other identifier: CP24001
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Coronary Chronic Total Occlusions; Ischemic Heart Disease; Ischemic Heart Disease (IHD); Ischemic Heart Disease Chronic

Keywords

CTO-PCI; CTO

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Successful Recanalization

  From the beginning of the study procedure to the end of the study procedure

• In-Hospital: Frequency of Major Adverse Cardiac Events (MACE)

  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)

  30 Day Follow-up

• Safety - Blood Vessel Perforation

  From the beginning of the study procedure to the end of the study procedure

• Procedure: Serious Adverse Events Related to Study Device or Procedure

  From the beginning of the study procedure until discharge or 24 hours after the procedure (whichever comes first)

Study Arms (1)

CTO-PCI Procedure with Acolyte Catheter System

EXPERIMENTAL

Device: CTO-PCI Procedure with Acolyte Catheter System

Interventions

CTO-PCI Procedure with Acolyte Catheter System DEVICE

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.

CTO-PCI Procedure with Acolyte Catheter System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Elumn8 Medical: lead

Study Sites (5)

NCH Healthcare System

Naples, Florida, 34102, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

St. Francis Hospital

Roslyn, New York, 11576, United States

Location

PharmaTex Research

Amarillo, Texas, 79106, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 28, 2025
• Study Start: August 6, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)