Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic

Conditions

• Thoracoabdominal Aortic Aneurysm, Without Rupture

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• B-TEVAR device — DEVICE
  Implantation of the Branched Thorcoabdominal aortic anerysm device

Study Details

An investigator-initiated, prospective, consecutively enrolling, non-randomized single institution clinical evaluation of the safety and effectiveness of branched and fenestrated-branched endovascular stent grafts to preserve branch vessels when used in the treatment of patients with thoraco-abdominal aortic aneurysms. The study evaluates non-FDA-approved off the shelf and custom made branched and fenestrated-branched stent grafts manufactured by Cook Medical. The primary objectives of this study are to determine whether fenestrated-branched and branched endovascular grafts are a safe and effective method of treating patients with thoraco-abdominal aortic aneurysms.

Key Dates

Start date

Aug 31, 2012

Status verified

May 2023

Primary completion

Aug 31, 2025

Completion

Aug 31, 2028

Study Design

Enrollment

290 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: B -TEVAR
  Implantation of the B-TEVAR device

Primary Outcome Measure

The effectiveness of multi-branched endovascular grafts will be determined by evaluating the proportion of patients that achieve Treatment Success [ Time Frame: 12 months post-procedure. ]

Central Contacts

• Sandra Mata-Diaz, MPH
  2065988487
  [email protected]

Locations (1)

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