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

Simpson Interventions, Inc.

Status

Not yet enrolling

Conditions

Ischemic Heart Disease

Ischemic Heart Disease Chronic

Coronary Chronic Total Occlusions

Ischemic Heart Disease (IHD)

Treatments

Device: CTO-PCI Procedure with Acolyte Catheter System

Study type

Interventional

Funder types

Industry

Identifiers

NCT06795763

CP24001

Details and patient eligibility

About

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.

Full 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.

Enrollment

115 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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