Safety and Effectiveness of Physician-Modified Fenestrated and Branched Aortic Endografting for the Treatment of Thoracoabdominal and Pararenal Aortic Aneurysms

Part of paid clinical trials in Lebanon, New Hampshire.

Sponsor
Bjoern D. Suckow
Study ID
NCT06501872
Status
Recruiting
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Conditions

  • Aortic Aneurysm

Eligibility Criteria

Sex
ALL
Age
50 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • Physician-modified aortic endograft — DEVICE
    Use of physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair.

Study Details

The primary clinical objective of this study is to evaluate the safety and effectiveness of a physician-modified, fenestrated and branched aortic endoprosthesis for the treatment of thoracoabdominal aortic aneurysms (TAAAs). The goal of the primary analysis is to demonstrate both the safety and effectiveness of using a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft as compared to previously published results of open surgical replacement of the aneurysmal aorta.

Key Dates

Start date
Dec 10, 2024
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2031

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Main Arm
    Use of a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair.
  • Experimental: Expanded Access Arm
    Use of a physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal, thoracic, or abdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair in an expanded use population.

Primary Outcome Measure

30 day survival [ Time Frame: 30 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756
Delaney Gray
[email protected]
603-650-6228
Bjoern D Suckow, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Dartmouth-Hitchcock Medical Center· Lebanon, NH

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