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

N/AEnrolling By InvitationNCT06795763

Simpson Interventions, Inc.115 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

115

Conditions

Coronary Chronic Total Occlusions Ischemic Heart Disease

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

NCH Healthcare System

Naples, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

St. Francis Hospital

Roslyn, New York, United States

PharmaTex Research

Amarillo, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 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)).

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

Secondary Outcomes

Successful Recanalization

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

Time frame: From the beginning of the study procedure to the end of the study procedure

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.

Time frame: 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)

Any serious adverse experience that includes cardiac death, target lesion revascularization, or post-procedural myocardial infarction.

Time frame: 30 Day Follow-up

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).

Time frame: From the beginning of the study procedure to the end of the study procedure

Procedure: Serious Adverse Events Related to Study Device or Procedure

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

Time frame: 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

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

Time frame: 30 Day Follow-up

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

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

Time frame: 3-Month Follow-up

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

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

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

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

Time frame: 30 Day Follow-up

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

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

Time frame: From the beginning of the study procedure to the end of the study procedure

Procedure: Fluoroscopy Time

Total fluoroscopy time during procedure

Time frame: From the beginning of the study procedure to the end of the study procedure

Procedure: Technical Success

Crossing chronic total occlusion and/or re-entry success

Time frame: 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

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

Time frame: Baseline and 30 Days

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

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

Time frame: Baseline and 3 Months