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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