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Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

This study is currently recruiting participants.
Verified March 2013 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00833924
First received: January 30, 2009
Last updated: March 16, 2013
Last verified: March 2013
History of Changes
  Purpose

The Zenith(R) Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft in the treatment of 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:

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • Composite rate of adverse clinical/device events [ Time Frame: during and after implantation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 177
Study Start Date: May 2009
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833924

Contacts
Contact: Alison Conovaloff, MS 765-463-7537 aconovaloff@medinst.com

  Hide Study Locations
Locations
United States, California
University of California, San Francisco, Div. Vascular Surgery and San Francisco VAMC Recruiting
San Francisco, California, United States, 94143
Contact: Linda M. Reilly, MD     415-353-4366     reillyl@surgery.ucsf.edu    
Stanford University Medical Center Recruiting
Stanford, California, United States, 94305
Contact: Jason T. Lee, MD     650-724-8292     jtlee@stanford.edu    
United States, Connecticut
Yale New Haven School of Med., Dept. of Vascular Surgery Recruiting
New Haven, Connecticut, United States, 06510
Contact: Bart Muhs, MD     203-815-6377     bart.muhs@yale.edu    
United States, Florida
University of Florida, Vascular Surgery Recruiting
Gainesville, Florida, United States, 32610
Contact: Robert J. Feezor, MD     352-273-5484     robert.feezor@surgery.ufl.edu    
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Richard P. Cambria, MD     617-726-8278     rcambria@partners.org    
United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: John Rectenwald, MD     734-763-0250     jrectenw@umich.edu    
Spectrum Health Butterworth Active, not recruiting
Grand Rapids, Michigan, United States, 49546
William Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Graham Long, MD     248-898-2197     glong@beaumont.edu    
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Gustavo Oderich, MD     507-255-7208        
United States, Missouri
St. John's Mercy Medical Center Recruiting
St. Louis, Missouri, United States, 63141
Contact: Vito Mantese, MD     314-251-4294     vito.mantese@mercy.net    
Barnes-Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63141
Contact: Patrick Geraghty, MD     314-362-6490     geraghtyp@wudosis.wustl.edu    
United States, New Jersey
Morristown Memorial Hospital Active, not recruiting
Morristown, New Jersey, United States, 07960
United States, New York
New York University Hospital Recruiting
New York, New York, United States, 10016
Contact: Neal Cayne, MD     212-263-7311     neal.cayne@med.nyu.edu    
New York Presbyterian Hospital - Columbia and Cornell Recruiting
New York, New York, United States, 10032
Contact: James McKinsey, MD     212-342-3255     jfm2111@columbia.edu    
University of Rochester, Strong Memorial Hospital Active, not recruiting
Rochester, New York, United States, 14642
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27955
Contact: Mark Farber, MD     919-966-3391     farberm@med.unc.edu    
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Matthew Eagleton, MD     216-444-8758        
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Contact: Gary Ansel, MD     614-263-1011     gansel@mocvc.com    
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Edward Woo, M.D.     215-662-7836     wooe@uphs.upenn.edu    
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Satish Muluk, MD     412-359-8820     muluk@usa.net    
United States, Virginia
Fairfax Inova Hospital Active, not recruiting
Falls Church, Virginia, United States, 22042
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Benjamin Starnes, MD     206-744-3370     starnes@u.washington.edu    
United States, Wisconsin
St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Mark Mewissen, MD     414-385-2429     mark.mewissen@aurora.org    
Canada, Quebec
Jewish General Hospital Withdrawn
Montreal, Quebec, Canada, H3T 1E2
China
Queen Mary Hospital Active, not recruiting
Hong Kong, China
Germany
St. Franziskus Hospital Active, not recruiting
Munster, Germany, 48145
Russian Federation
CELT Hospital Active, not recruiting
Shosse Entuziastov, Moscow, Russian Federation, 111123
Sweden
Malmo University Hospital Active, not recruiting
Malmo, Sweden
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Ronald Fairman, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00833924     History of Changes
Other Study ID Numbers: 08-013, 370016
Study First Received: January 30, 2009
Last Updated: March 16, 2013
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
Iliac Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on May 16, 2013