Acolyte Catheter System for Coronary Artery Disease

Overseen By Kin F Chan, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Simpson Interventions, Inc.

Disqualifiers: Stroke, Peptic ulcer, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

115 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults over 18 with chronic total occlusions in coronary arteries, who still have symptoms like chest pain or heart failure after medical therapy. They must be able to follow the study plan and attend all follow-ups. Women of childbearing age need a negative pregnancy test.

Inclusion Criteria

Subject is willing and able to provide written informed consent

I am a woman who can have children and have a negative pregnancy test.

I can follow the study's requirements and attend all follow-up visits.

Exclusion Criteria

History of allergy to iodinated contrast that cannot be managed medically

History of bleeding diathesis or coagulopathy or refusal of blood transfusions

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Participants undergo the CTO-PCI procedure using the Acolyte Catheter System to evaluate safety and effectiveness

1 day

1 visit (in-person)

In-Hospital Monitoring

Participants are monitored for major adverse cardiac events (MACE) until discharge or 24 hours post-procedure

1-2 days

30-Day Follow-up

Participants are monitored for non-serious and serious adverse events related to the study device or procedure

30 days

3-Month Follow-up

Participants are monitored for serious adverse events and changes in angina symptoms

3 months

Treatment Details

Interventions

• CTO-PCI Procedure with Acolyte Catheter System

Trial Overview The Acolyte Catheter System is being tested during CTO-PCI procedures on patients with blocked coronary arteries. The study checks how safe and effective it is for guiding wires and catheters through these blockages.

Participant Groups

Group I: CTO-PCI Procedure with Acolyte Catheter System Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Simpson Interventions, Inc.

Lead Sponsor

Trials

1

Recruited

120+