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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Elumn8 Medical
Study ID
NCT06795763
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CTO-PCI Procedure with Acolyte Catheter System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Aug 6, 2025
Status verified
May 2026
Primary completion
Sep 1, 2026
Completion
Sep 1, 2027

Study Design

Enrollment
115 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CTO-PCI Procedure with Acolyte Catheter System

Primary Outcome Measure

Procedure Success - Visualization of Guidewire [ Time Frame: From the beginning of the study procedure to the end of the study procedure ]

Locations (5)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322-
Piedmont Heart InstituteAtlantaGeorgia30309-
Minneapolis Heart Institute FoundationMinneapolisMinnesota55407-
St. Francis HospitalRoslynNew York11576-
PharmaTex ResearchAmarilloTexas79106-

Find similar trials in Atlanta, GA

By research site
Emory University Hospital· Atlanta, GAPiedmont Heart Institute· Atlanta, GAMinneapolis Heart Institute Foundation· Minneapolis, MNSt. Francis Hospital· Roslyn, NYPharmaTex Research· Amarillo, TX

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