Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00833924
First received: January 30, 2009
Last updated: August 6, 2014
Last verified: August 2014
  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 used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg 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:
  • Composite rate of adverse clinical/device events [ Time Frame: during and after implantation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 272
Study Start Date: May 2009
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (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
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

Contacts
Contact: Dedra Markovich 765-463-7537 dmarkovich@medinst.com

  Hide Study Locations
Locations
United States, California
University of California, San Francisco, Div. Vascular Surgery and San Francisco VAMC Active, not recruiting
San Francisco, California, United States, 94143
Stanford University Medical Center Active, not recruiting
Stanford, California, United States, 94305
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale New Haven School of Med., Dept. of Vascular Surgery Active, not recruiting
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Washington Hospital Center Active, not recruiting
Washington, District of Columbia, United States, 20010
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, Georgia
Piedmont Hospital Recruiting
Atlanta, Georgia, United States, 30309
United States, Iowa
Iowa Heart Center Active, not recruiting
West Des Moines, Iowa, United States, 50266
United States, Massachusetts
Massachusetts General Hospital Active, not recruiting
Boston, Massachusetts, United States, 02114
University of Massachusetts Medical School Active, not recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan Hospital Active, not recruiting
Ann Arbor, Michigan, United States, 48109
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
Missouri Heart Center Recruiting
Columbia, Missouri, United States, 65201
Barnes-Jewish Hospital Active, not recruiting
St. Louis, Missouri, United States, 63141
St. John's Mercy Medical Center Active, not recruiting
St. Louis, Missouri, United States, 63141
United States, New Jersey
Cooper University Hospital Active, not recruiting
Camden, New Jersey, United States, 08103
Newark Beth Israel Medical Center Active, not recruiting
Livingston, New Jersey, United States, 07039
Morristown Memorial Hospital Active, not recruiting
Morristown, New Jersey, United States, 07960
United States, New York
New York Presbyterian Hospital - Columbia and Cornell Active, not recruiting
New York, New York, United States, 10032
New York University Hospital Recruiting
New York, New York, United States, 10016
Contact: Neal Cayne, MD    212-263-7311    neal.cayne@med.nyu.edu   
University of Rochester, Strong Memorial Hospital Active, not recruiting
Rochester, New York, United States, 14642
United States, North Carolina
University of North Carolina Active, not recruiting
Chapel Hill, North Carolina, United States, 27955
Wake Forest University Health Sciences Active, not recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic Active, not recruiting
Cleveland, Ohio, United States, 44195
Riverside Methodist Hospital Active, not recruiting
Columbus, Ohio, United States, 43214
United States, Oregon
Bend Memorial Clinic Recruiting
Bend, Oregon, United States, 97701
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   
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, Tennessee
Baptist Memorial Hospital-Memphis Active, not recruiting
Memphis, Tennessee, United States, 38120
United States, Virginia
Fairfax Inova Hospital Active, not recruiting
Falls Church, Virginia, United States, 22042
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
United States, Washington
Harborview Medical Center Active, not recruiting
Seattle, Washington, United States, 98104
United States, West Virginia
Charleston Area Medical Center Memorial Hospital Active, not recruiting
Charleston, West Virginia, United States, 25304
United States, Wisconsin
Gundersen Lutheran Medical Center Active, not recruiting
La Crosse, Wisconsin, United States, 54601
St. Luke's Medical Center Active, not recruiting
Milwaukee, Wisconsin, United States, 53215
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: August 6, 2014
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 August 20, 2014