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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the safety and effectiveness of the coraFlex, coraForce, and coraCross catheters for crossing chronic total occlusions of the coronary arteries. The study will compare the rate of procedure success to success rates from previous trials. Participants will undergo percutaneous coronary intervention (PCI) for a chronic total occlusion and be followed for 30 days post-procedure.

Research Team

Lorenzo Azzalini, MD

Principal Investigator

University of Washington

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+