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

Cook Group

Status: Completed

Conditions: Aortic Aneurysm, Abdominal

Treatments: Device: Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft

Study type: Interventional

Funder types: Industry

Identifiers

NCT01652235

07-003

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Endovascular

Experimental group

Description:

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

Treatment:

Device: Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft