The COSIRA-II trial is being undertaken by Neovasc to determine the safety and effectiveness of the Reducer™ System for the treatment of refractory angina.
U.S. patients with chronic refractory angina who are not candidates for further revascularization surgery may be eligible for this trial. Certain medical criteria must be met before enrolling in the COSIRA-II clinical trial.
Trial eligibility and locations can be found here >
COSIRA-II FREQUENTLY ASKED QUESTIONS FOR HEALTH CARE PROFESSIONALS
What is the COSIRA-II clinical trial?
COSIRA-II (COronary SInus Reducer for the Treatment of Refractory Angina) is a clinical trial designed to evaluate the safety and effectiveness of the Neovasc Reducer™ device in treating patients suffering from refractory angina. Refractory angina – long-lasting, debilitating chest pain that cannot being controlled by traditional medicine or surgical procedures – effects millions of people world-wide. In the U.S., the Reducer is currently approved for ‘Investigational Use Only’ which means that at this time, only select patients can receive this treatment by participating in the COSIRA-II clinical trial.
Where is this trial being held?
Medical Centers throughout North America are currently being evaluated and as they sign on location and contact information will be available here>
How do I enroll a patient in the trial?
U.S. patients with chronic refractory angina who are not candidates for further revascularization surgery may be eligible for this trial. Certain medical criteria must be met before enrolling in the COSIRA-II clinical trial. Eligibility and trial locations can be found here >
Who is eligible to participate?
COSIRA-II is for patients, 18 years old and up, with chronic refractory angina despite receiving optimal medical therapy and who are not candidates for revascularization surgery. Certain medical criteria must be met before enrolling in a clinical trial. Eligibility and locations for the COSIRA-II trial can be found here>
How is the procedure performed?
Implantation of the Neovasc Reducer is usually performed under local anesthesia using a catheter inserted through a small needle puncture in the jugular vein. Patients are typically discharged within 24 hours.
Watch an animation of the procedure here >.
Have patients already been treated with Reducer™?
The Reducer System has been approved in many other countries around the world, but has not been approved for use in the United States. To date, over 2,000 patients have had the Reducer device implanted. Neovasc hopes COSIRA-II will provide the necessary data for the Food & Drug Administration (FDA) to approve the device to treat patients in the United States.
How do patients respond?
Relief varies by patient and depends on a number of factors. Many patients who have had the Reducer implanted report relief from angina symptoms sometimes as early as 6 weeks after the procedure, with most patients reporting improvement within 3 months.