Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft

The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.

Study Overview

• Status: Completed
• Conditions: Abdominal Aortic Aneurysms; Aorto-iliac Aneurysms; Iliac Aneurysms
• Intervention / Treatment: Device: Zenith(R) Low Profile AAA Endovascular Graft

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Queen Mary Hospital
• Germany
  • Munster, Germany, 48145
    • St. Franziskus Hospital
• Russian Federation
  • Moscow, Russian Federation, 111123
    • CELT Hospital
• Sweden
  • Malmo, Sweden
    • Malmö University Hospital
• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco, Div. Vascular Surgery and San Francisco VAMC
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven School of Med., Dept. of Vascular Surgery
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida, Vascular Surgery
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospital
    • Grand Rapids, Michigan, United States, 49546
      • Spectrum Health Butterworth
    • Royal Oak, Michigan, United States, 48073
      • William Beaumont Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Mercy Hospital
    • Saint Louis, Missouri, United States, 63141
      • Barnes-Jewish Hospital
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Memorial Hospital
  • New York
    • New York, New York, United States, 10016
      • New York University Hospital
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital - Cornell
    • Rochester, New York, United States, 14642
      • University of Rochester, Strong Memorial Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27955
      • University of North Carolina
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43214
      • Ohio Health Research Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Virginia
    • Falls Church, Virginia, United States, 22042
      • Fairfax INOVA Hospital
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Abdominal aortic, aortoiliac, and iliac aneurysms of appropriate size
• Vessels suitable for endovascular access and aneurysm repair

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
• Unsuitable arterial anatomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 1; Treatment with Endovascular Graft	Device: Zenith(R) Low Profile AAA Endovascular Graft; The Zenith(R) Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients With Major Adverse Events (MAE)	MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation.	30-day
Patients With Device Failures	Device success at 12-month is defined as: Technical Success (successful access of the aneurysm site, deployment of the graft in the intended location, and patency of the graft at the time of deployment completion intra-operatively), and freedom from the following at 12 months: Type I or type III endoleaks requiring re-intervention, Aneurysm rupture or conversion to open surgical repair, and Aneurysm enlargement greater than 0.5 cm.	12-month

Collaborators and Investigators

• Sponsor: Cook Group Incorporated

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (ACTUAL): October 1, 2011
• Study Completion (ACTUAL): June 1, 2016

Study Registration Dates

• First Submitted: January 30, 2009
• First Submitted That Met QC Criteria: January 30, 2009
• First Posted (ESTIMATE): February 2, 2009

Study Record Updates

• Last Update Posted (ACTUAL): April 4, 2018
• Last Update Submitted That Met QC Criteria: March 8, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Endovascular; Abdominal Aortic Aneurysms; Low Profile
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal; Iliac Aneurysm
• Other Study ID Numbers: 08-013; 370016