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Clinical Trials/NCT06795763
NCT06795763Enrolling By InvitationNot Applicable

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

Elumn8 Medical6 sites in 1 country115 target enrollmentStarted: August 6, 2025Last updated:
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Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Sponsor
Enrollment
115
Locations
6
Primary Endpoint
Procedure Success - Visualization of Guidewire
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

CTO-PCI Procedure with Acolyte Catheter System

Experimental

Intervention: CTO-PCI Procedure with Acolyte Catheter System (Device)

Outcomes

Primary Outcomes

Procedure Success - Visualization of Guidewire

Time Frame: 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

Time Frame: 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)).

Secondary Outcomes

  • 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)
  • 30-Day: Non-serious Adverse Events Related to Study Device or Procedure(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))
  • 30-Day: Serious Adverse Events Related to Study Device or Procedure(30 Day Follow-up)
  • 3-Month: Serious Adverse Events Related to Study Device or Procedure(3-Month Follow-up)
  • Procedure: Non-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))
  • Procedure: Time for Guidewire to Cross Chronic Total Occlusion (CTO)(From the beginning of the study procedure to the end of the study procedure)
  • Procedure: Fluoroscopy Time(From the beginning of the study procedure to the end of the study procedure)
  • Procedure: Technical 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(Baseline and 30 Days)
  • Change from Baseline in Seattle Angina Questionnaire-7 at 3 Months(Baseline and 3 Months)

Investigators

Sponsor
Elumn8 Medical
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (6)

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