Back to resultsZenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study (ZLP)
Primary Purpose
Abdominal Aortic Aneurysm, Aorto-iliac Aneurysm, Iliac Aneurysm
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
ZLP
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Aortic Aneurysm focused on measuring aortic aneurysm, iliac aneurysm, endovascular procedures
Eligibility Criteria
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
Sites / Locations
- Nara Medical University
- Jikei University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Endovascular Repair
Outcomes
Primary Outcome Measures
Composite rate of adverse clinical/device events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01326884
Brief Title
Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study
Acronym
ZLP
Official Title
ZLP Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm, Aorto-iliac Aneurysm, Iliac Aneurysm
Keywords
aortic aneurysm, iliac aneurysm, endovascular procedures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Endovascular Repair
Intervention Type
Device
Intervention Name(s)
ZLP
Intervention Description
ZLP Graft
Primary Outcome Measure Information:
Title
Composite rate of adverse clinical/device events
Time Frame
During (day 1) and after implantation through 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald M. Fairman, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nara Medical University
City
Nara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
Jikei University Hospital
City
Tokyo
ZIP/Postal Code
105-8461
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study
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