Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

Cook Group

Status: Completed

Conditions: Aorto-iliac Aneurysms; Iliac Aneurysms; Abdominal Aortic Aneurysms

Treatments: Device: Zenith(R) Low Profile AAA Endovascular Graft

Study type: Interventional

Funder types: Industry

Identifiers

NCT00833924

08-013

370016

Details and patient eligibility

About

The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Abdominal aortic, aortoiliac, and iliac aneurysms of appropriate size
• Vessels suitable for endovascular access and aneurysm repair

Exclusion criteria

• Less than 18 years of age
• Inability or refusal to give informed consent
• Disease considerations that would compromise patient safety or study outcomes
• Unsuitable arterial anatomy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

1

Other group

Description:

Treatment with Endovascular Graft

Treatment:

Device: Zenith(R) Low Profile AAA Endovascular Graft