Device to treat chest pain when the heart's small blood vessels don't work well

Plain-English translation of NCT04606459 on ClinicalTrials.gov ↗ · Source last updated September 2023 · Translation generated June 2026 · How we translate trials

This study doesn't follow the usual testing phases — it may be an observational study or a different type of research.

What is this trial?

This trial is testing a medical device called the Neovasc Reducer that is implanted in a vein near the heart to help relieve severe chest pain. The device is being compared to standard heart medications to see if it works better for patients whose chest pain has not improved despite taking recommended medicines. This type of chest pain happens when the heart's smallest blood vessels don't deliver enough blood during stress or activity.

Millions of patients suffer from chest pain caused by tiny blood vessels in the heart that don't work properly, and current medicines don't adequately relieve their symptoms or improve their quality of life. Researchers want to see if this new treatment can give these patients better relief and reduce their need for hospitalizations and repeat medical procedures.

Do you qualify?

You likely qualify if…

you are between 18 and 85 years old
you have severe chest pain (class III or IV) that has not improved despite taking guideline-recommended heart medications
you have been diagnosed with microvascular disease (disease of the heart's smallest blood vessels) confirmed by heart catheterization testing
you have evidence of reduced blood flow to your heart muscle on non-invasive testing such as a stress test
you are willing and able to understand and sign an informed consent form

You likely don't qualify if…

you have had a heart attack or acute heart syndrome within the past 3 months
you have had a stent placed or bypass surgery within the past 6 months
you have heart failure that is not well controlled or were hospitalized for heart failure in the past 3 months
you have severe lung disease, kidney disease requiring dialysis, or serious valve disease
you are a woman of childbearing potential (have not gone through menopause or had surgery to prevent pregnancy)

What participation looks like

If you are randomly assigned to receive the device, you will have a catheterization procedure where doctors place the small Reducer device in a vein near your heart; this is similar to other heart procedures you may have had. You will then be followed with regular visits to monitor how well the device is working and how your symptoms improve. If you are assigned to the medication group, you will receive optimized heart medications and be followed to see how well they control your symptoms.

AI-generated summary from trial data · Jun 2, 2026 · Not medical advice

Trial locations(1 site)

Germany

Center of Cardiology, Cardiology I, university hospital Mainz, Mainz, Rhineland-Palatinate