Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study
Overview
A prospective study conducted in Japan to collect confirmatory peri-operative and 30-day information on use of the Zenith LP AAA Graft.
Full Title of Study: “ZLP Clinical Study”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: November 2012
Interventions
- Device: ZLP
- ZLP Graft
Arms, Groups and Cohorts
- Other: 1
- Endovascular Repair
Clinical Trial Outcome Measures
Primary Measures
- Composite rate of adverse clinical/device events
- Time Frame: During (day 1) and after implantation through 12 months
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 20 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Cook Group Incorporated
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Ronald M. Fairman, MD, Principal Investigator, University of Pennsylvania
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