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Evaluation of Branch Endografts in the Treatment of Aortic Aneurysms

StatusRecruiting
PhaseNot applicable
Started2012-01-25
View on ClinicalTrials.gov ↗

Amendment history

2026-06-12
Study Status v16
Re-verified, no change to tracked fields
2025-06-04
Study Status, Study Description v15
Study description+7 characters
Study Update as of 53/31/20242025; 179186 subjects successfully have been implanted with the Zenith t-Branch Device and 1 subject has been implanted with the Arch Branch to date and recruitment is ongoing. Arch Branch Subject Cohort enrollment is open.
2024-06-03
Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v14
Enrollment target225→235
Study arms1→2
InterventionsZenith® t-Branch (Device)→Terumo Arch Branch (Device), Zenith® t-Branch (Device)
Eligibility criteria+3,123 characters
Zenith t-Branch Eligibility Criteria: Inclusion Criteria The patient must have one of the followin [...] the abdominal aorta, or <7mm or >28mm in the iliac arteries Terumo Arch Branch Eligibility Criteria Inclusion Criteria The subject must have one of the following: Degenerative, atherosclerotic aneurysm involving the ascending aorta, aortic arch or proximal descending aorta ≥55 mm in diameter or > 50 mm with a history of growth ≥5 mm in the last 6 months, or [...]
Secondary endpointsdetails revised at 1 of 1 entry
Primary endpoints1 entry, revised
Early Mortality & Stroke
Study description+47 characters
Study Update: As as of 15/2231/2024;174 179 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing. Arch Branch Subject Cohort enrollment is open.
Collaborators1 to 2 entries
Bolton Medical
2024-01-22
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions v13
Lead sponsorLee, W. Anthony, M.D. FACS→Baptist Health South Florida
Study description+1 characters
Study Update as: As of 21/2022/20232024;159174 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing.
2023-02-20
Study Status, Study Description, Contacts/Locations v12
Study description-1 characters
Study Update as of 122/2220/20212023;143159 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing.
Study sites1 entry, revised
Baptist Health South Florida|Boca Raton Regional Hospital (BRRH)
Show 11 earlier versions
2021-12-22
Study Status, Study Description v11
Study description+1 characters
Study Update as of 212/1622/2021;140143 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing.
2021-02-16
Study Status, Study Description v10
Study description-1 characters
Study Update as of 122/3116/20192021;122140 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing.
2019-12-31
Study Status, Study Description, Study Design v9
Primary completion date2021-09→2031-12
Completion date2022-01→2032-01
Enrollment target125→225
Study description+1 characters
Study Update as of 1112/1631/20182019;95122 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing.
2018-11-16
Study Status, Oversight, Study Description, Study Design v8
PhasePhase 2→Not applicable
Start date2012-01→2012-01-25
Study descriptionrevised
Study Update as of 1011/3116/20172018;8495 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing.
2017-10-31
Study Status, Study Description, Eligibility v7
Eligibility criteria+204 characters
[...] hology (aneurysm, ulcer or chronic dissection) of any size. Additional criteria for LP material • Iliofemoral access vessels <8mm or with significant atherosclerotic occlusive disease that would require an iliac conduit as determined by the Principle Investigator Exclusion Criteria General Criteria Life-expectancy less tha [...]
Study description+2 characters
Study Update as of 410/231/2017;7784 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing.
2017-04-02
Study Status, Study Description, Study Design, Eligibility v6
Primary completion date2017-02→2021-09
Enrollment target75→125
Eligibility criteria-168 characters
Inclusion Criteria: SubjectThe patient must have one of the following: Degenerative, atherosclerotic thoracoabdominal, suprarenal and juxtarenal aortic aneurysmaneurysms (fusiform or saccular):≥55mm in diameter in a male or ≥50mm in diameter in a female, or Thoracoabdominal aortic aneurysm with a history of growth ≥0.5 cm per year., or Penetrating ulcers: ≥20mm in depth or Chronic type B aortic dissections: ≥55mm50mm total aortic diameter or Symptomatic pathology (aneurysm, ulcer or chronic dissection) of any size. Exclusion Criteria: General Criteria Life-expectancy less than 12 months Refusa [...] [...]
Study description-2 characters
Study Update as of 54/122/20162017; 6277 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing.
2016-05-12
Study Status, Study Description, IPDSharing v5
Primary completion date2016-01→2017-02
Completion date2021-01→2022-01
Study description+3 characters
Study Update as of 95/312/152016; 5062 subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing.
2015-09-03
Study Status, Study Description, Study Design v4
Completion date2020-01→2021-01
Enrollment target55→75
Study description-3 characters
Study Update as of11of 9/133/201415; 4150 Subjectssubjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing.
2014-11-13
Study Status, Study Description, Study Design, Arms and Interventions v3
Primary completion date2014-01→2016-01
Completion date2019-01→2020-01
Enrollment target30→55
Study arms0→1
Study description+2 characters
Study Update as ofof11/13/2014; 7/25/2013 2541 Subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing.
2013-07-31
Study Status, Study Description, Eligibility v2
Eligibility criteria+14 characters
[...] eria Uncontrolled systemic infection Untreatable malignancy Heart Attack(MI) or stroke in last 90 days Unstable/Ruptured aneurysm Uncont [...]
Study descriptionrevised
Study Update as of 87/2925/2012 142013 25 Subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing
2012-08-29
Study Status, Sponsor/Collaborators, Study Description, Eligibility v1
Lead sponsorW Anthony Lee, MD→Lee, W. Anthony, M.D. FACS
Eligibility criteria-61 characters
[...] eria Uncontrolled systemic infection Untreatable malignancy Chronic renal insufficiency (eGFR <30), except in chronic renal failure on hemodialysis MI or stroke in last 90 days Unstable/Ruptured aneurysm Uncontrollable anaphylaxis to iodinated contrast Known aller [...]
Study description+140 characters
Study Update as of 8/29/2012 14 Subjects successfully have been implanted with the Zenith t-Branch Device to date and recruitment is ongoing
2012-01-31
Original filing
Zenith t-Branch Study Cohort: The purpose of this study is to collect information on the Cook Zenith t-Branch endovascular stent-graft system and the Terumo Arch Branch for the treatment of aortic aneurysms. Terumo Arch Branch Study Cohort: The purpose of this additional study arm to the current IDE clinical trial is to collect a priori information on the Terumo Arch Branch Endograft for the treatment of proximal thoracic aortic pathologies that cannot be treated with conventional thoracic endografts.
Trial Details
NCT Number NCT01524211
Lead Sponsor Baptist Health South Florida
Collaborators: William Cook Australia, Bolton Medical
Conditions Thoracoabdominal Aortic Aneurysm, Aortic Arch Aneurysm
Enrollment 235 participants
Start Date 2012-01-25
Primary Completion 2031-12 (estimated)
Study Completion 2032-01 (estimated)
Updated on ClinicalTrials.gov 2026-06-15