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Recruiting NCT04747626

B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair

No phase Interventional Thoracic Aortic Aneurysm Aortic Dissection Congenital Aortic Anomaly

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: B-SAFER.
Who it may be relevant to
Registry conditions: Thoracic Aortic Aneurysm, Aortic Dissection, Congenital Aortic Anomaly. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed 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.

Interventions

  • Device B-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.

Primary outcome measures

  • All-cause mortality [Time frame: Up to 30 days]
  • Stroke, excluding TIA [Time frame: Up to 30 days]
  • Paralysis, excluding paraparesis [Time frame: Up to 30 days]
  • Technical success [Time frame: 24 hours]
  • Patency of all graft/endograft components [Time frame: At hospital discharge or at 1 month]
  • Complete sealing of the aortic pathology [Time frame: At hospital discharge or 1 month]
Secondary outcome measures (12)
  • Aortic related death [Time frame: Up to 36 months after the index procedure]
  • Pseudoaneurysm at the treatment sites [Time frame: Up to 36 months after the index procedure]
  • Unanticipated aortic or branch-related re-operation [Time frame: Up to 36 months after the index procedure]
  • Late Type I endoleak [Time frame: Up to 36 months after the index procedure]
  • Late Type III endoleak [Time frame: Up to 36 months after the index procedure]
  • Non-cardiac/non-aortic re-operations [Time frame: Up to 36 months after the index procedure]
  • Vocal Cord paralysis [Time frame: Up to 36 months after the index procedure]
  • Myocardial infarction [Time frame: Up to 36 months after the index procedure]
  • Respiratory failure [Time frame: Up to 36 months after the index procedure]
  • Renal failure requiring dialysis [Time frame: Up to 36 months after the index procedure]
  • Thromboembolic events [Time frame: Up to 36 months after the index procedure]
  • Failed patencies in graft, or endovascular stent-graft including the branch(es) [Time frame: Up to 36 months after the index procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Cleveland Clinic — Cleveland

Publications

  • Roselli EE, Vargo PR, Bakaeen F, Koprivanac M, Burns D, Kuramochi Y, Gillinov M; B-SAFER Investigators. Branched stented anastomosis frozen elephant trunk repair: Early results from a physician-sponsored investigational device exemption study. J Thorac Cardiovasc Surg. 2024 Sep;168(3):746-756. doi: 10.1016/j.jtcvs.2023.09.069. Epub 2023 Oct 5. PMID 37802330

Identifiers

NCT: NCT04747626 · G200342

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗