B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair (B-SAFER)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    100
  • sponsor
    Eric Roselli, M. D.
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Updated on 1 May 2022
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aortic aneurysm

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.

Description

The proposed Investigational Device Exemption (IDE) is to assess the safety and preliminary effectiveness of the simplified hybrid frozen elephant trunk repair technique Branched Stented Anastamosis Frozen Elephant Trunk Repair (B-SAFER) which involves a physician modified endovascular stentgraft to treat the proximal aorta in subjects with aortic disease involving multiple segments. The study will also evaluate the device functionality when using this operative technique for device implantation including multiple components.

Details
Condition Thoracic Aortic Aneurysm, Aortic Dissection, Congenital Aortic Anomaly
Treatment B-SAFER
Clinical Study IdentifierNCT04747626
SponsorEric Roselli, M. D.
Last Modified on1 May 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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