B-SAFER: Branched Stented Anastomosis Frozen Elephant Trunk Repair

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Eric Roselli, M. D.
Study ID
NCT04747626
Status
Recruiting
Apply to this trial

Conditions

  • Aortic Dissection
  • Congenital Aortic Anomaly
  • Thoracic Aortic Aneurysm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • B-SAFER — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Mar 25, 2021
Status verified
Oct 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
590 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Implantation of a physician-modified endovascular stentgraft(s) to treat the proximal aorta in subjects with aortic disease involving multiple segments.

Primary Outcome Measure

All-cause mortality [ Time Frame: Up to 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cleveland ClinicClevelandOhio44195
Eric Roselli, M. D.
[email protected]
216-444-0995
Yuki Kuramochi, BSN, RN
[email protected]
216-445-4063
Eric Roselli, M. D. (PRINCIPAL_INVESTIGATOR)
Faisal Bakaeen, M. D. (SUB_INVESTIGATOR)
Patrick Vargo, M. D. (SUB_INVESTIGATOR)
Edward Soltez, M. D. (SUB_INVESTIGATOR)
Michael Tong, M. D. (SUB_INVESTIGATOR)
Shinya Unai, M. D. (SUB_INVESTIGATOR)
Haytham Elgharably, M. D. (SUB_INVESTIGATOR)
Francis Caputo, M. D. (SUB_INVESTIGATOR)
Lee Kirksey, M. D. (SUB_INVESTIGATOR)
John Quatromoni, M. D. (SUB_INVESTIGATOR)
Marc Gillinov, M. D. (SUB_INVESTIGATOR)
Marijan Koprivanac, M. D. (SUB_INVESTIGATOR)
Sean Steenberge, M. D. (SUB_INVESTIGATOR)
Ali Khalifeh, M. D. (SUB_INVESTIGATOR)
Ravi Ambani, M. D. (SUB_INVESTIGATOR)
Anthony Zaki, M. D. (SUB_INVESTIGATOR)
Tarek Malas, M. D. (SUB_INVESTIGATOR)
Xiaoying Lou, M. D. (SUB_INVESTIGATOR)
Donna Kilmmaliardjuk, M. D. (SUB_INVESTIGATOR)

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By research site
Cleveland Clinic· Cleveland, OH

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