Clinical trial 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
Official title: Chronic Total Occlusion (CTO) Crossing, Re-entry and Imaging With the Acolyte™ Catheter System in Subjects Undergoing Percutaneous Coronary Interventional (PCI) Procedures
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Chronic Total Occlusions
Ischemic Heart Disease
Ischemic Heart Disease (IHD)
Ischemic Heart Disease Chronic
Keywords: CTO-PCI
CTO
Lead sponsor: Simpson Interventions, Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-28
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Procedure Success - Visualization of Guidewire
timeFrame: From the beginning of the study procedure to the end of the study procedure
measure: Procedure Success - Absence of Major Adverse Cardiac Events
timeFrame: From the beginning of the study procedure until discharge or 24 hours after the procedure (whichever comes first)
Secondary outcomes:
measure: Successful Recanalization
timeFrame: From the beginning of the study procedure to the end of the study procedure
measure: In-Hospital: Frequency of Major Adverse Cardiac Events (MACE)
timeFrame: From the beginning of the study procedure until discharge or 24 hours after the procedure (whichever comes first)
measure: 30-Day: Frequency of Major Adverse Cardiac Events (MACE)
timeFrame: 30 Day Follow-up
measure: Safety - Blood Vessel Perforation
timeFrame: From the beginning of the study procedure to the end of the study procedure
measure: Procedure: Serious Adverse Events Related to Study Device or Procedure
timeFrame: From the beginning of the study procedure until discharge or 24 hours after the procedure (whichever comes first)
measure: 30-Day: Serious Adverse Events Related to Study Device or Procedure
timeFrame: 30 Day Follow-up
measure: 3-Month: Serious Adverse Events Related to Study Device or Procedure
timeFrame: 3-Month Follow-up
measure: Procedure: Non-serious Adverse Events Related to Study Device or Procedure
timeFrame: From the beginning of the study procedure until discharge or 24 hours after the procedure (whichever comes first)
measure: 30-Day: Non-serious Adverse Events Related to Study Device or Procedure
timeFrame: 30 Day Follow-up
measure: Procedure: Time for Guidewire to Cross Chronic Total Occlusion (CTO)
timeFrame: From the beginning of the study procedure to the end of the study procedure
measure: Procedure: Fluoroscopy Time
timeFrame: From the beginning of the study procedure to the end of the study procedure
measure: Procedure: Technical Success
timeFrame: From the beginning of the study procedure to the end of the study procedure
measure: Change from Baseline in Seattle Angina Questionnaire-7 at 30 Days
timeFrame: Baseline and 30 Days
measure: Change from Baseline in Seattle Angina Questionnaire-7 at 3 Months
timeFrame: Baseline and 3 Months
Other outcomes:
Locations:
city: Naples
country: United States
facility: NCH Healthcare System
state: Florida
Study officials:
References: