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

Launched by SIMPSON INTERVENTIONS, INC. · Jan 21, 2025

Keywords

ClinConnect Summary

The Acolyte CTO-PCI Study is a clinical trial designed to test a new catheter system that helps doctors treat patients with a specific heart condition called coronary chronic total occlusion (CTO). This condition occurs when one of the heart's arteries is completely blocked, leading to ongoing symptoms like chest pain or discomfort, even after taking medication. The study aims to see how safe and effective this new catheter system is for guiding the placement of tools used to open up the blocked artery during a minimally invasive procedure.

To participate in the study, patients must be over 18 years old, currently experiencing symptoms related to their heart condition, and scheduled for a procedure to improve blood flow. However, there are some important exclusions; for example, patients who have had a heart attack recently or who have certain medical conditions may not be eligible. Participants can expect to undergo the standard procedure while being monitored closely, and they will need to attend follow-up visits to ensure everything is going well. This trial is not recruiting just yet, so there’s no immediate action required, but it's a promising opportunity for those struggling with persistent heart issues.

Gender

ALL

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