Recruiting

Testing a new graft device for aortic arch repair surgery

Plain-English translation of NCT07089576 on ClinicalTrials.gov ↗ · Source last updated September 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 Arcevo LSA that surgeons use during open repair surgery for aortic arch aneurysms and aortic dissections. The device is a special graft—essentially a reinforced tube—designed to strengthen a weakened or torn aorta (your body's largest blood vessel) in the arch region. Researchers want to see if this treatment works safely and effectively for patients who need this type of surgery.

Aortic arch aneurysms and dissections are serious conditions where the aorta weakens or tears, which can be life-threatening. While surgery is often necessary, doctors want better tools to repair these delicate areas. This trial tests whether the new Arcevo LSA device can improve surgical outcomes and safety.

Do you qualify?

You likely qualify if…

you are between 18 and 80 years old at the time of surgery
you have been diagnosed with an aortic arch aneurysm or aortic dissection (acute, subacute, or chronic) confirmed by CT scan within 90 days
your aorta measurements fall within specific size ranges required for the device to work safely
your aortic anatomy is suitable for this type of repair (your doctor will determine this from imaging)
you can have surgery within 90 days of enrolling in the study
you are willing and able to return for follow-up visits as scheduled

You likely don't qualify if…

you are pregnant or planning to become pregnant during the study
you have a medical condition that would shorten your life expectancy to less than 2 years
you already have an aortic stent graft device in place that would conflict with this new device
you are unable or unwilling to return for follow-up appointments
you are unwilling to accept blood transfusions if medically necessary during or after surgery

What participation looks like

If you enroll, you will undergo open surgery where surgeons use the Arcevo LSA device to repair your aortic arch. Most participants (117 out of 132) will have chronic aneurysms or dissections, while a smaller group (15 participants) will have acute or subacute dissections. After surgery, you will attend regular follow-up visits so doctors can monitor how well the repair is working and check for any complications.

AI-generated summary from trial data · Aug 26, 2026 · Not medical advice

Trial locations(23 sites)

United States

University of Alabama, Birmingham, Alabama

University of Southern California, Los Angeles, California

University of Colorado Hospital, Aurora, Colorado

MedStar Washington Health, Washington D.C., District of Columbia

University of Florida-Shands, Gainesville, Florida