Taking people in United StatesNo phase

Testing a new stented graft for repairing the aortic arch in adults

Tests a branched stent graft repair in adults with aortic arch disease.

Key facts

Who runs it: Eric Roselli, M. D.
Where: Cleveland, United StatesSee the site
Trial code: NCT04747626
Registry title: B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair
Status: Recruiting
People taking part: 590 people, planned
Started: 25 Mar 2021
Expected to end: 31 Dec 2030
Type of study: Interventional
Treatments tested: B-SAFER
Record updated: 9 October 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with disease of the main body artery in the chest (thoracic aorta) that needs repair of several damaged segments. It tests a hybrid repair using a modified stent graft.

Age: 18 years or older
Sex: All sexes
Disease stage: Needs repair of several damaged parts of the thoracic aorta, for at least one of: a thoracic aortic aneurysm at higher risk of bursting or problems, an acute aortic dissection (a tear in the artery wall) needing urgent repair, or an inborn aortic disease needing repair. Expected to live more than two years after repair.
Earlier treatment: Cannot have received a study product (device, drug or biologic) in another active study within 6 months before the implant.

Main reasons for not taking part

Not fit for open surgery that needs the blood flow to be stopped
In a coma or with severe, permanent lack of blood flow to the brain
Active body-wide infection that could harm the surgery result
Bleeding problem that cannot be corrected
Pregnancy

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

At least 18 years of age
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
Expected life expectancy of greater than two years after repair
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

Who cannot take part

Subject is unfit for open surgical repair involving circulatory arrest
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
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
Subject has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure
Subject has an uncorrectable bleeding anomaly
Subject is comatose or suffering from irreversible severe brain malperfusion
Subject has known sensitivity to components of the devices
Subject is pregnant

Where in United States

Cleveland ClinicCleveland, United StatesContact: Eric Roselli, M. D.Taking people

About the trial

What the trial wants to find out

A prospective, single-center, non-blind, non-randomized safety and feasibility study of the hybrid repair of thoracic aortic pathologies requiring repair of the aortic arch proximal to the origin of innominate artery.

The group in the trial

TreatmentTreatment being tested
Implantation of a physician-modified endovascular stentgraft(s) to treat the proximal aorta in subjects with aortic disease involving multiple segments.
Treatment: B-SAFER