B-SAFER Technique for Aortic Dissection
(B-SAFER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is the B-SAFER technique generally safe for humans?
The B-SAFER technique, also known as the frozen elephant trunk repair, has been studied for various aortic conditions and is considered favorable and safe, although some adverse events have been noted with certain grafts. Safety has been associated with the complexity of the procedure and the specific techniques used to manage different parts of the aorta.12345
What makes the B-SAFER treatment unique for aortic dissection?
What data supports the effectiveness of the B-SAFER treatment for aortic dissection?
The B-SAFER treatment, which is a type of frozen elephant trunk (FET) technique, has shown promising early results in treating complex aortic diseases, as it combines elements of stented anastomosis and hybrid stent grafts. Studies on similar FET techniques have demonstrated positive outcomes in both acute and chronic aortic dissections, suggesting potential effectiveness for B-SAFER in aortic dissection cases.12379
Who Is on the Research Team?
Eric Roselli, M. D.
Principal Investigator
The Cleveland Clinic
Are You a Good Fit for This Trial?
This trial is for adults over 18 with a life expectancy of more than two years who need repair or replacement of the thoracic aorta due to conditions like aneurysms, dissections, or congenital diseases. Participants must be able to consent and not have device sensitivities, uncorrectable bleeding disorders, active infections that could affect surgery outcomes, involvement in other studies with investigational products within the last six months, medical issues affecting trial participation, pregnancy, or severe brain malperfusion.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Implantation of a physician-modified endovascular stentgraft to treat the proximal aorta in subjects with aortic disease involving multiple segments
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of device functionality and monitoring for adverse events
What Are the Treatments Tested in This Trial?
Interventions
- B-SAFER
B-SAFER is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eric Roselli, M. D.
Lead Sponsor
The Cleveland Clinic
Collaborator