Physician-Modified Fenestrated and Branched Aortic Endografting for TAAA

Conditions

• Aortic Aneurysm, Thoracoabdominal

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

Apr 22, 2020

Status verified

Apr 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2031

Study Design

Enrollment

80 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Main Arm - Physician-modified fenestrated endovascular graft
  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 - Physician-modified fenestrated endovascular graft.
  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

• David P. Kuwayama, M.D., MPA
  [email protected]

Locations (2)

Find similar trials in New Haven, CT

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