Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Clinical Study

Cook Research Incorporated28 enrolled

Overview

The Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic aneurysms.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Aortic Aneurysm, Abdominal

Interventions

Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular GraftDEVICE

Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Abdominal aortic aneurysm \> 5.0 cm or 2 times the normal aortic diameter * Abdominal aortic aneurysm with history of growth \> 0.5 cm in 6 months * Penetrating juxtarenal aortic ulcer \> 10 mm in depth and 20 mm in diameter Exclusion Criteria: * Age \< 18 years * Life expectancy \< 2 years * Pregnant or breast feeding * Inability or refusal to give informed consent * Unwilling or unable to comply with the follow-up schedule * Additional medical restrictions as specified in the Clinical Investigation Plan * Additional anatomical restrictions as specified in the Clinical Investigation Plan

Locations (2)

Mount Sinai-West

New York, New York, United States

New York Presbyterian Hospital System

New York, New York, United States

Outcomes

Primary Outcomes

Technical Success:

Successful access of the aneurysm site and deployment of the Zenith® Fenestrated AAA Endovascular Graft or the Zenith® p-Branch™ in the intended location. The endovascular graft and all vessels targeted with fenestrations must be patent at the time of deployment completion as evidenced by intraoperative angiography

Time frame: Immediately post graft deployment

Procedural Success

Technical Success, with all of the following at post-procedure (within 30 days): * No type I or type III endoleaks; * No procedure related serious adverse events or major complications; * Patency of the endovascular graft and all vessels targeted with fenestrations as evidenced by CT scan, angiography or by duplex ultrasound in those patients experiencing renal failure or otherwise unable to undergo contrast enhanced CT scan.

Time frame: Within 30 days post graft deployment

Treatment Success

Procedural Success, with all of the following at 12 months: * No type I or type III endoleaks; * No serious adverse events or major complications; * No aneurysm enlargement greater than 0.5 cm; * Patency of the endovascular graft and all vessels targeted with fenestrations as evidenced by CT scan, angiography or by duplex ultrasound in those patients experiencing renal failure or otherwise unable to undergo contrast enhanced CT scan.

Time frame: 12 months

Data from ClinicalTrials.gov

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