Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00833924
Recruitment Status : Completed
First Posted : February 2, 2009
Results First Posted : January 29, 2016
Last Update Posted : April 4, 2018
Information provided by (Responsible Party):
Cook Group Incorporated

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysms Iliac Aneurysms Aorto-iliac Aneurysms Device: Zenith(R) Low Profile AAA Endovascular Graft Not Applicable

Access to an investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft
Study Start Date : May 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Patients With Major Adverse Events (MAE) [ Time Frame: 30-day ]
    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.

  2. Patients With Device Failures [ Time Frame: 12-month ]

    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00833924

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

Responsible Party: Cook Group Incorporated Identifier: NCT00833924     History of Changes
Other Study ID Numbers: 08-013
First Posted: February 2, 2009    Key Record Dates
Results First Posted: January 29, 2016
Last Update Posted: April 4, 2018
Last Verified: March 2018

Keywords provided by Cook Group Incorporated:
Low Profile
Abdominal Aortic Aneurysms

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases