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Coronary Chronic Total OcclusionsNCT06795763

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

A study testing CTO-PCI Procedure with Acolyte Catheter System in people with Coronary Chronic Total Occlusions and Ischemic Heart Disease, run by Elumn8 Medical at 5 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CTO-PCI Procedure with Acolyte Catheter System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
115 participants
Where
5 sitesUnited States
Study dates
6 Aug 2025to 1 Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

5 sites in 1 country

United States5 sites

  • PharmaTex Research

    Amarillo, Texas, 79106

  • Piedmont Heart Institute

    Atlanta, Georgia, 30309

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • St. Francis Hospital

    Roslyn, New York, 11576

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
CTO-PCI Procedure with Acolyte Catheter System
Keywords
CTO-PCI, CTO
Medical subject headings
Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CTO-PCI Procedure with Acolyte Catheter SystemDevice

    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 groups in NCT06795763
Study groupRoleWhat they receive
CTO-PCI Procedure with Acolyte Catheter SystemExperimentalNot described
Receives: Device: CTO-PCI Procedure with Acolyte Catheter System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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)).

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

Secondary outcomes (14)

  1. Successful Recanalization

    Frequency of successful recanalization defined as angiographic confirmation of crossing the chronic total occlusion and restoring blood flow to the affected area

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

  2. 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.

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

  3. 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.

    Measured: 30 Day Follow-up

  4. 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).

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

  5. Procedure: Serious Adverse Events Related to Study Device or Procedure

    Frequency of serious adverse events (SAEs) related to the study device or procedure

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

  6. 30-Day: Serious Adverse Events Related to Study Device or Procedure

    Frequency of serious adverse events (SAEs) related to the study device or procedure

    Measured: 30 Day Follow-up

  7. 3-Month: Serious Adverse Events Related to Study Device or Procedure

    Frequency of serious adverse events (SAEs) related to the study device or procedure

    Measured: 3-Month Follow-up

  8. Procedure: Non-serious Adverse Events Related to Study Device or Procedure

    Frequency of non-serious adverse events related to the study device or procedure

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

  9. 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

    Measured: 30 Day Follow-up

  10. Procedure: Time for Guidewire to Cross Chronic Total Occlusion (CTO)

    Time from initial CTO guidewire entered into guide to guidewire crossing chronic total occlusion

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

  11. Procedure: Fluoroscopy Time

    Total fluoroscopy time during procedure

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

  12. Procedure: Technical Success

    Crossing chronic total occlusion and/or re-entry success

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

  13. Change from Baseline in Seattle Angina Questionnaire-7 at 30 Days

    Change from Baseline in Mean Seattle Angina Questionnaire-7 at 30 Days

    Measured: Baseline and 30 Days

  14. Change from Baseline in Seattle Angina Questionnaire-7 at 3 Months

    Change from Baseline in Mean Seattle Angina Questionnaire-7 at 3 Months

    Measured: Baseline and 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2025
  2. Study start6 Aug 2025
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
115 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06795763
Sponsor's protocol ID
CP24001
Status last verified
May 2026
First submitted
16 Jan 2025
Last updated
19 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing CTO-PCI Procedure with Acolyte Catheter System in people with Coronary Chronic Total Occlusions and Ischemic Heart Disease, run by Elumn8 Medical at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Procedure Success - Visualization of Guidewire (time frame: From the beginning of the study procedure to the end of the study procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06795763.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.

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