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

Chronic Total Occlusion (CTO) Crossing, Re-entry and Imaging With the Acolyte™ Catheter System in Subjects Undergoing Percutaneous Coronary Interventional (PCI) Procedures

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 115 (estimated)
• Sponsor: Elumn8 Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Chronic Total Occlusions
• Ischemic Heart Disease
• Ischemic Heart Disease (IHD)
• Ischemic Heart Disease Chronic

Interventions

Type	Name	Description
DEVICE	CTO-PCI Procedure with Acolyte Catheter System	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.

Timeline

• Start date: 2025-08-06
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2025-01-28
• Last updated: 2026-02-23

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study