CORA Catheters for Coronary Artery Disease

(Cora CTO Trial)

Overseen By Vicky Joshi

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: ReFlow Medical, Inc.

Must not be taking: Antiplatelets, Anticoagulants

Disqualifiers: Recent MI, Stroke, Pregnancy, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Procedure day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests three new catheter devices—coraFlex, coraForce, and coraCross—to determine if they safely and effectively open blocked heart arteries. Researchers aim to compare these devices' success rates with those from past trials. Ideal candidates for this trial have experienced significant heart artery blockage for over three months and show symptoms like chest pain or shortness of breath related to heart disease. Participants will undergo a procedure to treat the blockage and will be monitored for 30 days. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking heart treatment advancements.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you must be able to tolerate dual antiplatelet therapy (DAPT) with aspirin and a P2Y12 inhibitor, and you should not have allergies to certain anticoagulant therapies.

What prior data suggests that these catheters are safe for coronary artery procedures?

Research shows that the coraFlex, coraForce, and coraCross catheters have been evaluated for safety in treating heart disease. A related study demonstrated good safety results when using catheters in heart arteries. This indicates that catheters like coraFlex, coraForce, and coraCross are generally safe with a low risk of serious side effects.

These catheters are currently in a late-stage trial, which suggests existing evidence supports their safety. Late-stage trials typically proceed only after earlier studies have confirmed a treatment's general safety for people. Although specific data about these catheters is not detailed here, their use in advanced trials implies an acceptable safety profile. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the coraCross, coraFlex, and coraForce catheters for coronary artery disease because they introduce innovative catheter technologies that could enhance precision and effectiveness. Unlike traditional treatments like balloon angioplasty and stent placement, these catheters are designed to offer better control and flexibility, potentially reducing complications and improving outcomes. This could mean a more tailored approach to opening up blocked arteries, possibly leading to quicker recoveries and better long-term heart health for patients.

What evidence suggests that this trial's catheters could be effective for coronary artery disease?

Research has shown that the coraFlex, coraForce, and coraCross catheters are promising tools for treating complete blockages in heart arteries. Previous patients demonstrated that these catheters can successfully navigate and clear difficult blockages during heart procedures. The coraCatheters are specially designed to handle complex artery conditions, making them valuable in procedures that open blocked arteries. Over the past decade, results have been positive, supporting their potential effectiveness. This trial will evaluate the use of coraFlex, coraForce, and/or coraCross catheters in a single treatment arm, suggesting that these catheters could improve the success of treatments for coronary artery disease. ^{1 2 3 6 7}

Who Is on the Research Team?

Lorenzo Azzalini, MD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for adults over 18 with coronary artery disease who have a blocked artery that's been clogged for more than 3 months. They should be candidates for heart procedures like PTCA, stenting, and emergency bypass surgery. Pregnant women, those with recent heart attacks or strokes, or severe other health issues are excluded.

Inclusion Criteria

Subject willing and able to provide informed consent and able to comply with the study protocol and follow up

I have symptoms or signs of heart disease due to a blocked artery and am scheduled for a procedure to open it.

I have a blocked artery in my heart that has been blocked for over 3 months.

Exclusion Criteria

My target lesion is inside a stent placed less than 9 months ago.

I have not had a stroke or mini-stroke in the last 6 months.

I have not had any heart surgery or procedures in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo percutaneous coronary intervention (PCI) using the coraFlex, coraForce, and/or coraCross catheters for crossing chronic total occlusions

Procedure day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure, with assessments through 30 days post-intervention

30 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• coraCross
• coraFlex
• coraForce

Trial Overview The study tests the safety and effectiveness of three catheters: coraFlex, coraForce, and coraCross in opening up completely blocked arteries in the heart during PCI. Success rates will be compared to past trials' data.

How Is the Trial Designed?

Group I: coraFlex, coraForce, and/or coraCross Catheters Experimental Treatment 3 Interventions

Single arm

Who Is Running the Clinical Trial?

ReFlow Medical, Inc.

Lead Sponsor

Trials

8

Recruited

1,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05848232?term=AREA%5BConditionSearch%5D(%22Coronary%20Occlusion%22)&rank=2

Single-Arm Study Evaluating Use of the CORA Catheters ... The goal of this clinical trial is to evaluate the safety and effectiveness of the coraFlex, coraForce, and coraCross catheters for crossing chronic total ...

2. withpower.com withpower.com/trial/phase-3-coronary-occlusion-5-2023-222d3

CORA Catheters for Coronary Artery Disease ... The goal of this clinical trial is to evaluate the safety and effectiveness of the coraFlex, coraForce, and coraCross catheters for crossing chronic total ...

3. evtoday.com evtoday.com/articles/2021-aug/the-reflow-medical-innovation-algorithm

The Reflow Medical Innovation Algorithm Based on positive results over the past 10 years, Reflow Medical plans to expand the reach of its continuous feedback loop—the Innovation Algorithm—among its ...

4. ctv.veeva.com ctv.veeva.com/study/single-arm-study-evaluating-use-of-the-cora-catheters-for-the-crossing-of-coronary-chronic-total-occ

Single-Arm Study Evaluating Use of the CORA Catheters for ... The goal of this clinical trial is to evaluate the safety and effectiveness of the coraFlex, coraForce, and coraCross catheters for crossing ...

5. reflowmedical.com reflowmedical.com/reflow-medical-introduces-the-coracatheters-line-and-expands-into-complex-percutaneous-coronary-interventions-pci/

Reflow Medical Introduces the coraCatheters™ Line and ... A complete line of state-of-the-art microcatheters engineered to access and cross complex and challenging lesions in percutaneous coronary interventions.

6. reflowmedical.com reflowmedical.com/checking-the-pulse-new-updates-for-q1-2024/

Checking the Pulse: New Updates for Q1 2024 Professor Thomas Zeller, MD, presented 1-year results from the DEEPER OUS clinical trial (NCT03807531) at VIVA23. The trial evaluates the safety ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31967723/

Outcomes and safety of concurrent coronary ... Our study demonstrates the efficacy and safety of concurrent catheterization of coronary arteries and lower limb arteries, regardless of the time interval ...