RecruitingNot ApplicableNCT04747626

B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair

Sponsor

Eric Roselli, M. D.

Enrollment

590 participants

Start Date

Mar 25, 2021

Study Type

INTERVENTIONAL

Conditions

Aortic Dissection Thoracic Aortic Aneurysm Congenital Aortic Anomaly

Summary

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

Min Age: 18 Years

Inclusion Criteria4

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

Exclusion Criteria8

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
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 an uncorrectable bleeding anomaly
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 is pregnant

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEB-SAFER

Simplified 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.

Locations(1)

Cleveland Clinic

Cleveland, Ohio, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04747626

Related Trials

False Lumen Treatment for Prevention of Aortic Growth Using Shape Memory Polymer - First-in-Human Study

NCT065509862 locations

Terumo Aortic Global Endovascular Registry

NCT0424646358 locations

GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections

NCT0682799013 locations

Montalcino Aortic Consortium: Precision Medicine for Heritable Thoracic Aortic Disease

NCT0400597620 locations

Antibacterial Tactics Based on Presepsin Level in Thoracic Aorta Surgery Patients

NCT063362131 location