Acolyte Catheter System for Coronary Artery Disease

Enrolling by invitation at 3 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new tool called the Acolyte Catheter System to determine its safety and effectiveness for treating blocked heart arteries. These blockages, known as chronic total occlusions, can cause ongoing chest pain or heart problems even with medication. The trial seeks participants who continue to experience symptoms like chest pain despite taking medication for heart disease. Those dealing with persistent heart symptoms and scheduled for a procedure to open blocked arteries might find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It mentions that participants should be on medical therapy, so you might be able to continue your current medications, but it's best to confirm with the study team.

What prior data suggests that the Acolyte Catheter System is safe for use in CTO-PCI procedures?

In a previous study, the Acolyte Catheter System showed promise in treating coronary artery disease. Research indicates that this system helps doctors see blockages more clearly and position wires more accurately during procedures, enhancing safety and effectiveness.

Initial findings suggest that patients tolerated the Acolyte Catheter System well during procedures. Early tests with patients reported no major safety concerns, which is encouraging for those considering joining a trial using this system.

While researchers continue to study the Acolyte Catheter System, the data so far supports its safety in humans. However, as with any medical procedure, some risk remains. It's important to consult a doctor to understand these risks before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Acolyte Catheter System is unique because it offers a novel approach to treating coronary artery disease, specifically for chronic total occlusions (CTO). Unlike standard techniques, which often involve complex procedures with longer recovery times, the Acolyte Catheter System is designed to simplify the CTO-PCI procedure. It potentially reduces procedure time and improves precision by using advanced catheter technology, which enhances navigation through blocked arteries. Researchers are excited because this system could make the treatment safer and more effective, ultimately improving patient outcomes.

What evidence suggests that the Acolyte Catheter System is effective for coronary artery disease?

Research has shown that the Acolyte Catheter System, used to open blocked heart arteries, can help treat coronary chronic total occlusions. In this trial, participants will undergo the CTO-PCI Procedure with the Acolyte Catheter System. A previous study linked successful procedures using drug-eluting stents (special tubes that release medication) to a lower risk of death or heart attack. The Acolyte System aims to enhance the precision and safety of these procedures. Early findings suggest that this system aids doctors in placing guidewires and catheters more effectively, potentially leading to better outcomes for patients with blocked heart arteries. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06795763

Acolyte CTO-PCI Study: Imaging and Catheter System to ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5990674/

Five-Year Outcomes of Successful Percutaneous Coronary ... In this study, successful CTO PCI with DESs was associated with a higher risk of repeat PCI for the target vessel, but showed a reduced incidence of death or MI ...

3. hmpgloballearningnetwork.com hmpgloballearningnetwork.com/site/cathlab/news/simpson-interventions-announces-first-patients-treated-clinical-trial-its-acolyte

Simpson Interventions Announces First Patients Treated in ... The Acolyte System represents a promising approach to enable interventional cardiologists to more effectively, consistently and safely treat ...

4. ctv.veeva.com ctv.veeva.com/study/acolyte-cto-pci-study-imaging-and-catheter-system-to-treat-patients-with-coronary-chronic-total-occ

Acolyte CTO-PCI Study: Imaging and Catheter System to Treat ... 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 ...

5. dicardiology.com dicardiology.com/content/simpson-interventions-receives-fda-breakthrough-device-designation-acolyte-image-guided

Simpson Interventions Receives FDA Breakthrough ... The Acolyte Image Guided Crossing and Re-Entry Catheter System is designed to facilitate the placement and positioning of guidewires and catheters within the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10715934/

Clinical Experience of a Novel Optical Coherence ... We demonstrated a first-in-human case of successful antegrade dissection and re-entry using an image-guided re-entry catheter that enables real-time ...

7. citoday.com citoday.com/news/cto-pci-study-begins-for-simpsons-acolyte-catheter-system

CTO-PCI Study Begins for Simpson's Acolyte Catheter ... “The ability to clearly visualize the CTO in real-time and precisely position a guidewire with the same device potentially represents an ...