COSIRA II Clinical Study Patient Information
Learn more about the COSIRA II clinical study, including the purpose of the study, who can participate, and participating site locations throughout the United States.
Do you suffer from chronic chest pain?
If you experience chronic chest pain despite appropriate medically-prescribed therapy and are not a candidate for another procedure, talk to your doctor about potential eligibility for participating in a study to investigate a novel treatment option.
Common symptoms of angina:
COSIRA II is a clinical study designed to evaluate the safety and effectiveness of a medical device, known as the Shockwave™ Reducer, in treating patients in the United States and Canada suffering from chronic chest pain.
The Shockwave Reducer device
The Reducer is a small, hourglass shaped tube implanted into the main vessel that collects blood once it leaves the heart muscle. The device is intended to create back pressure that increases oxygen-rich blood flow to areas of the heart not receiving normal blood flow.
The Reducer has been studied extensively overseas and is commercially available in Europe. In the United States, the device is currently approved for ‘Investigational Use Only’, which means that only select patients can receive this treatment by participating in the COSIRA II clinical study at this time.
Who can participate in the clinical study?
You may be able to participate in the COSIRA II study if you meet these criteria:
- You are a patient suffering from angina symptoms during ordinary physical activity such as walking at normal pace or climbing one flight of stairs despite receiving medical therapy
- You had a previous procedure (stent or surgery) that did not relieve your symptoms
- You are on several medications to control your chronic chest pain but still suffer from symptoms
What will happen if you join the COSIRA II clinical study?
If your doctor thinks you would be a good candidate for this study, you will be evaluated to see if you are eligible to participate. You may:
- Receive a study-related physical exam
- Walk on a treadmill to assess your chest pain symptoms
- Give blood for lab testing
If you participate in the study, the Reducer device may be implanted in a relatively quick procedure under local anesthesia using a catheter inserted through a small needle above your shoulder. Patients are typically discharged on the same day. You will also be required to visit the study site for follow-up visits (or will be contacted by phone) at 6 months, 12 months, 2 years, 3 years, 4 years, and 5 years to assess your symptoms, quality of life, and medications.