New scaffold device for blocked arteries below the knee

Plain-English translation of NCT06071429 on ClinicalTrials.gov ↗ · Source last updated February 2026 · Translation generated August 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 new device called the MAGNITUDE BRS System, which is designed to open narrowed arteries below the knee in people with chronic limb-threatening ischemia—a serious condition where poor blood flow threatens the health of the leg and foot. The device is compared to a standard treatment called angioplasty to see whether this new treatment works better and is safe. About 276 people will be randomly assigned to receive either the new device or the standard treatment.

Blocked arteries below the knee are difficult to treat and can lead to serious complications, including amputation. This trial exists to find out whether the new treatment can help patients with this condition better than current standard approaches.

Do you qualify?

You likely qualify if…

you have chronic limb-threatening ischemia with symptoms affecting your legs or feet
you are 18 years of age or older
you have a narrowed artery below the knee that can be treated with this device
you are willing to complete all follow-up visits for at least 12 months, including imaging tests
your doctor has confirmed that the blocked vessel can be crossed with a guidewire before you are enrolled

You likely don't qualify if…

you have a previous stent placed in the target artery that has become blocked again
the blocked artery segment is too long (more than 11 cm) or too short (less than 14 mm)
your blocked artery is too small or too large for the device (less than 2.75 mm or more than 3.75 mm)
you have other significant blockages in the same vessel that cannot be treated

What participation looks like

If you join this trial, you will receive either the new MAGNITUDE BRS device or standard angioplasty treatment to open your blocked artery. You will be randomly assigned to one of these two groups. Before and after the procedure, you will have imaging tests (angiograms) to monitor how well the treatment is working. You will need to visit the clinic regularly for at least 12 months to have your progress checked and ensure the treatment continues to work safely.

AI-generated summary from trial data · Aug 27, 2026 · Not medical advice

Trial locations(3 sites)

United States

NYU Langone Health, New York, New York

CUMC/NYP, New York, New York

Staten Island University Hospital - Northwell Health, Staten Island, New York