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NCT01326884 Clinical Trial

Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study

Abdominal Aortic Aneurysm Clinical Trial

— ZLP  

Official title:
ZLP Clinical Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01326884
Other study ID # 10-004
Secondary ID
Status Completed
Phase N/A
First received March 21, 2011
Last updated March 11, 2013
Start date February 2011
Est. completion date November 2012

Study information
Verified date March 2013
Source Cook
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• ZLP
ZLP Graft

Locations
Country Name City State
Japan Nara Medical University Nara
Japan Jikei University Hospital Tokyo

Sponsors (1)
Lead Sponsor Collaborator
Cook

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Composite rate of adverse clinical/device events During (day 1) and after implantation through 12 months Yes
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