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NCT06795763

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
NAAges 18+InterventionalTreatment
Elumn8 Medical
~115 participants
Updated 2026-05-19 on ClinicalTrials.gov
What's tested:CTO-PCI Procedure with Acolyte Catheter System

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Procedure Success - Visualization of Guidewire
Measured over From the beginning of the study procedure to the end of the study procedure
+1 more outcome measured

Conditions

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

Explore related trials

Chronic Total Coronary Artery OcclusionIschemic Heart Disease

Where it's being run

5 sites across 4 states
Georgia2
Minnesota1
New York1
Texas1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Procedure Success - Visualization of GuidewireFrom 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 EventsFrom 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)).