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Catheter
CORA Catheters for Coronary Artery Disease (Cora CTO Trial)
Phase 3
Waitlist Available
Led By Lorenzo Azzalini, MD
Research Sponsored by ReFlow Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects experiencing clinical symptoms suggestive of ischemic heart disease or has evidence of myocardial ischemia attributed to the CTO target vessel and is scheduled for clinically indicated percutaneous revascularization
A minimum of one de novo or restenotic lesion with at least one target segment in a native coronary vessel meeting CTO criteria {defined as TIMI grade 0 flow} and estimated to be > 3 months duration by clinical history and/or comparison with a prior angiogram or electrocardiogram
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through hospital discharge or 24 hours post-procedure (whichever comes first)
Awards & highlights
Cora CTO Trial Summary
This trial studies new catheters to treat blocked arteries and compare their success rate to those used before.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks include bleeding at the catheter insertion site, infection risk from the procedure itself, potential damage to blood vessels by catheters or contrast media reactions.
Cora CTO Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have symptoms or signs of heart disease due to a blocked artery and am scheduled for a procedure to open it.
Select...
I have a blocked artery in my heart that has been blocked for over 3 months.
Select...
I am eligible for procedures to open blocked arteries in my heart.
Cora CTO Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through hospital discharge or 24 hours post-procedure (whichever comes first)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through hospital discharge or 24 hours post-procedure (whichever comes first)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Procedure success defined as technical success and the absence of in-hospital Major Adverse Cardiovascular Events (MACE)
Cora CTO Trial Design
1Treatment groups
Experimental Treatment
Group I: coraFlex, coraForce, and/or coraCross CathetersExperimental Treatment3 Interventions
Single arm
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Who is running the clinical trial?
ReFlow Medical, Inc.Lead Sponsor
7 Previous Clinical Trials
890 Total Patients Enrolled
Lorenzo Azzalini, MDPrincipal InvestigatorUniversity of Washington
2 Previous Clinical Trials
1 Trials studying Coronary Artery Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 or older and not pregnant.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.I had a heart attack within the last 3 days.I do not have severe heart issues or other health problems that could affect my study participation.I have symptoms or signs of heart disease due to a blocked artery and am scheduled for a procedure to open it.I have no allergies to blood thinners or a history of major bleeding recently.I have a blocked artery in my heart that has been blocked for over 3 months.The doctor thinks you may live for less than a year.I am eligible for procedures to open blocked arteries in my heart.I cannot tolerate dual antiplatelet therapy with aspirin and a P2Y12 inhibitor.I haven't had significant abnormal blood tests or signs of infection in the last month.My blocked artery has another narrowing above 75% near the blockage, but it will also be stented.A test shows a lot of blockage in the blood vessels due to a blood clot.You have stents in the target blood vessel that are broken.
Research Study Groups:
This trial has the following groups:- Group 1: coraFlex, coraForce, and/or coraCross Catheters
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Have the CoraFlex, coraForce, and/or coraCross Catheters received clearance from the US Food & Drug Administration?
"Owing to the existence of supporting data and successful rounds of testing, our team at Power has determined that coraFlex, coraForce, and/or coraCross Catheters can be rated a 3 on the safety scale."
Answered by AI
Is this research still open to new participants?
"Per the data hosted on clinicaltrials.gov, it appears that this trial is not currently enrolling patients even though its original post-date was June 1st of 2023 and most recent edit date occurred April 27th of 2023. Fortunately, there are 10 other studies actively seeking participants right now."
Answered by AI
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