B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEric Roselli, M. D.
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Subject is unfit for open surgical repair involving circulatory arrest
Subject is comatose or suffering from irreversible severe brain malperfusion
Subject has known sensitivity to components of the devices
Subject has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure
Trial design
Design model
Single group
Treatments tested in this trial
B-SAFER
DeviceSimplified hybrid frozen elephant trunk repair will be performed by utilizing B-SAFER technique which involves a physician modified endovascular stentgraft to treat the proximal aorta in subjects with aortic disease involving multiple segments.
Treatment groups
590 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
All-cause mortality
Individual rate of occurrence of the death from all-cause
Time frame
Up to 30 days2
Stroke, excluding TIA
Individual rate of occurrence of stroke
Time frame
Up to 30 days3
Paralysis, excluding paraparesis
Individual rate of occurrence of paralysis
Time frame
Up to 30 days4
Technical success
Composite of the following criteria: successful delivery of the device through the vasculature, successful deployment of the device at the intended location, and patient survival
Time frame
24 hoursSecondary outcomes
1
Aortic related death
Individual rate of the aortic related death
Time frame
Up to 36 months after the index procedure2
Pseudoaneurysm at the treatment sites
Individual rate of the pseudoaneurysm at the treatment sites
Time frame
Up to 36 months after the index procedure3
Unanticipated aortic or branch-related re-operation
Individual rate of the unanticipated aortic or branch-related re-operation
Time frame
Up to 36 months after the index procedure4
Late Type I endoleak
Individual rate of the Type I endoleak confirmed by CT imaging assessment
Time frame
Up to 36 months after the index procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Eric Roselli, M. D.
Lead sponsor
The Cleveland Clinic
Sponsor institution
The Cleveland Clinic
Collaborator
Source ClinicalTrials.gov