Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study

Cook Group

Status: Completed

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

Treatments: Device: ZLP

Study type: Interventional

Funder types: Industry

Identifiers

NCT01326884

10-004

Details and patient eligibility

About

A prospective study conducted in Japan to collect confirmatory peri-operative and 30-day information on use of the Zenith LP AAA Graft.

Enrollment: 27 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Less than 20 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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27 participants in 1 patient group

1

Other group

Description:

Endovascular Repair

Treatment:

Device: ZLP