Single-Arm Study Evaluating Use of the CORA Catheters for the Crossing of Coronary Chronic Total Occlusions

Launched by REFLOW MEDICAL, INC. · Apr 27, 2023

Keywords

ClinConnect Summary

This clinical trial aims to test the safety and effectiveness of special catheters called coraFlex, coraForce, and coraCross. These devices are designed to help doctors treat blocked arteries in the heart, specifically when there is a complete blockage known as a chronic total occlusion. If you are experiencing symptoms of heart issues and have been scheduled for a procedure to open these blocked arteries, you might be eligible to participate in this study. To qualify, you should be at least 18 years old, able to give consent, and have a specific type of blockage in your heart arteries that has been present for more than three months.

If you join the trial, you will undergo a procedure to open the blockage, and your health will be monitored for 30 days afterward to see how well the treatment works. It's important to note that the study is not yet recruiting participants, so it will be a while before enrollment starts. This trial could help improve treatments for patients with similar heart conditions in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Pre-Procedure Inclusion Criteria:
• • 1. Subject willing and able to provide informed consent and able to comply with the study protocol and follow up.
• • 2. Male or non-pregnant female ≥18 years of age at time of consent.
• • 3. 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.
• • 4. Subject is a candidate for PTCA, stenting, and emergency CABG.
• * Angiographic Inclusion Criteria:
• • 1. A minimum of one de novo 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.
• Exclusion Criteria:
• * Pre-procedure Exclusion Criteria:
• • 1. Subject unwilling or unable to comply with the protocol or follow-up requirements, in the opinion of the investigator.
• • 2. Subject life expectancy less than one year, in the opinion of the investigator.
• • 3. Subject is pregnant or planning to become pregnant during the course of the trial.
• • 4. Evidence of MI within 72 hours prior to the index procedure.
• • 5. History of stroke or transient ischemic attack within 6 months prior to the index procedure.
• • 6. Prior coronary interventional procedure (including coronary artery bypass graft surgery) of any kind within 30 days of the index procedure.
• • 7. Inability to tolerate DAPT with aspirin plus a P2Y12 inhibitor.
• • 8. Known allergies or sensitivities to heparin, antiplatelet drugs, or other anticoagulant therapies, which could not be substituted, including history of major bleeding event in the last 6 months.
• • 9. Allergy or sensitivity to contrast media that cannot be adequately pre-treated prior to the index procedure.
• 10. Subjects with known history of clinically significant abnormal laboratory findings ≤30 days prior to enrollment including:
• • 1. Neutropenia (\<1000 neutrophils/mm3)
• • 2. Thrombocytopenia (\<100,000 platelets/mm3)
• • 3. AST, ALT, ALP, or bilirubin \> 1.5 times ULN
• • 4. Serum creatinine \> 2.0 mg/dL
• • 11. Subject has signs/symptoms of systemic infection/sepsis (temperature ≥ 38.00 Celsius and WBC ≥12,000 cells/µL). If subject has localized infection or infection is adequately treated and controlled, per investigator discretion, patient may be enrolled.
• 12. Evidence of current clinical instability including:
• • 1. Sustained systolic blood pressure \<100 mmHg or cardiogenic shock
• • 2. Acute pulmonary edema or severe congestive heart failure (NYHA class IV)
• • 3. Known or suspected acute myocarditis, pericarditis, endocarditis, or cardiac tamponade
• • 4. Known or suspected dissecting aortic aneurysm
• • 5. Hemodynamically significant valvular heart disease, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease.
• • 6. Requires mechanical circulatory support (e.g., Impella) during index procedure
• • 13. Subject is currently enrolled in another investigational device or drug trial that interferes with the study endpoints.
• • 14. Any concurrent, medical, psychological, or social condition which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator.
• * Angiographic Exclusion Criteria:
• • 1. Target lesion is located within a stent (in-stent occlusion).
• • 2. Target vessel has other lesions proximal to the total occlusion with \>75% stenosis (based on visual estimate) unless there is planned stenting of the proximal lesion as well.
• • 3. Angiography demonstrates extensive lesion related thrombus (TIMI thrombus grade 3 or 4).
• • 4. Fractured stents in the target vessel.