New hybrid aortic repair technique aims to save lives

NCT ID NCT04747626

Recruiting now Disease control Sponsor: Eric Roselli, M. D. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new surgical technique called B-SAFER for people with complex aortic disease affecting multiple segments of the aorta. The procedure combines open surgery with a modified stent graft to repair the aortic arch and descending aorta in one operation. Researchers are enrolling 590 participants to see if the approach is safe and effective, measuring outcomes like death, stroke, and successful sealing of the aortic damage.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: B-SAFER technique (physician-modified endovascular stent graft used during frozen elephant trunk repair)
What this could lead to: If successful, this could offer a safer, more effective surgical option for people with complex aortic disease, potentially reducing death and stroke rates.
What could go wrong: This is an early feasibility study at a single center, not yet randomized or compared to standard care. The modified device may carry unknown risks like endoleak or graft failure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for AORTIC DISSECTION are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

Aortic Dissection congenital anomaly of the great arteries thoracic aortic aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

AORTIC DISSECTION CONGENITAL AORTIC ANOMALY THORACIC AORTIC ANEURYSM

Contacts and locations

Locations

Cleveland Clinic
RECRUITING

Cleveland, Ohio, 44195, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.