New hybrid aortic repair technique aims to save lives

NCT ID NCT04747626

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 590 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2021

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. At least 18 years of age 2. Subject is willing and able to give written informed consent to participate in the study or the subject's legally authorized representative has given written informed consent for the subject to participate in the study. 3. Expected life expectancy of greater than two years after repair 4. Subject has aortic pathology and requires repair or replacement of multiple damaged or diseased segments of the thoracic aorta (at least one of the following condition): Thoracic aortic aneurysm considered at increased risk for rupture or complications, Acute aortic dissection requiring urgent repair, Congenital aortic disease requiring repair Exclusion Criteria: 1. Subject is unfit for open surgical repair involving circulatory arrest 2. Subject is comatose or suffering from irreversible severe brain malperfusion 3. Subject has known sensitivity to components of the devices 4. Subject has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure 5. Subject is enrolled in another active study and has received an investigational product (device, pharmaceutical or biologic) within 6 months prior to the date of the implant or has not reached the primary endpoint of the study 6. Subject has an uncorrectable bleeding anomaly 7. Subject has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post- procedure 8. Subject is pregnant

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.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

New hybrid aortic repair technique aims to save lives

What the study statuses mean