Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00833924
First received: January 30, 2009
Last updated: February 9, 2016
Last verified: February 2016
  Purpose
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 Intervention
Abdominal Aortic Aneurysms
Iliac Aneurysms
Aorto-iliac Aneurysms
Device: Zenith(R) Low Profile AAA Endovascular Graft

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Patients With Major Adverse Events (MAE) [ Time Frame: 30-day ] [ Designated as safety issue: Yes ]
    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.

  • Patients With Device Failures [ Time Frame: 12-month ] [ Designated as safety issue: No ]

    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.



Enrollment: 120
Study Start Date: May 2008
Estimated Study Completion Date: June 2016
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833924

  Hide Study Locations
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
St. Louis, Missouri, United States, 63141
Mercy Hospital
St. Louis, Missouri, United States, 63141
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07960
United States, New York
New York Presbyterian Hospital - Cornell
New York, New York, United States, 10032
New York University Hospital
New York, New York, United States, 10016
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
China
Queen Mary Hospital
Hong Kong, China
Germany
St. Franziskus Hospital
Munster, Germany, 48145
Russian Federation
CELT Hospital
Shosse Entuziastov, Moscow, Russian Federation, 111123
Sweden
Malmo University Hospital
Malmo, Sweden
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Ronald Fairman, MD University of Pennsylvania
  More Information

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00833924     History of Changes
Other Study ID Numbers: 08-013  370016 
Study First Received: January 30, 2009
Results First Received: December 18, 2015
Last Updated: February 9, 2016
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency
Canada: Health Canada

Keywords provided by Cook:
Low Profile
Abdominal Aortic Aneurysms
Endovascular

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

ClinicalTrials.gov processed this record on July 21, 2016