Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study

Not Applicable

Completed

• Conditions: Abdominal Aortic Aneurysm; Aorto-iliac Aneurysm; Iliac Aneurysm
• Interventions: Device: ZLP

• Registration Number: NCT01326884
• Lead Sponsor: Cook Group Incorporated

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-03-21
• Study First Submitted QC: 2011-03-30
• Study First Posted: 2011-03-31
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-11
• Last Update Posted: 2013-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	ZLP	Endovascular Repair

Primary Outcome Measures

Name	Time	Method
Composite rate of adverse clinical/device events	During (day 1) and after implantation through 12 months

Trial Locations

Locations (2)

Nara Medical University; 🇯🇵 Nara, Japan

Jikei University Hospital; 🇯🇵 Tokyo, Japan