Zenith® Low Profile AAA Endovascular Graft

Overview

The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic, aortoiliac, and iliac aneurysms.

Full Title of Study: “Clinical Study Plan for the Zenith® Low Profile AAA Endovascular Graft”

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: January 23, 2017

Interventions

  • Device: Zenith Low Profile AAA Endovascular Graft and ancillary components
    • Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair

Arms, Groups and Cohorts

  • Experimental: Endovascular Graft
    • The Zenith Low Profile AAA Endovascular Graft and ancillary components

Clinical Trial Outcome Measures

Primary Measures

  • Number of Patients Without Major Adverse Events Within 30 Days
    • Time Frame: 30 days
    • Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation
  • Number of Patients With Device Success
    • Time Frame: 12 months
    • Device success will be measured with none of the following: type I or III endoleaks requiring re-intervention, graft limb occlusion, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm

Participating in This Clinical Trial

Inclusion Criteria

  • Subject has at least one of the following – Aortic or aortoiliac aneurysm – Iliac aneurysm – Aneurysm with a history of growth Exclusion Criteria:

  • Less than 18 years of age – Inability or refusal to give informed consent – Disease considerations that would compromise patient safety or study outcomes – Pregnant of breastfeeding or planning on becoming pregnant with 60 months – Unwilling to comply with the follow-up schedule

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cook Research Incorporated
  • Provider of Information About this Clinical Study
    • Sponsor

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