Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry

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:
NCT01540643
First received: February 23, 2012
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

The purpose of this registry is to obtain case reports of physician experience with the Spiral-Z® graft under routine clinical care.


Condition Intervention
Abdominal Aortic Aneurysm
Aorto-iliac Aneurysm
Device: Iliac Leg Graft

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Zenith® Spiral-Z® AAA Iliac Leg Graft Post-market Registry

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Assess short term and longer term outcomes, including outcomes related to patency, of the Zenith® Spiral-Z® AAA Iliac Leg Graft. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: March 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Abdominal aortic aneurysm Device: Iliac Leg Graft
Zenith® Spiral-Z® AAA Iliac Leg Graft

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients implanted with an FDA approved Zenith® Spiral-Z® AAA Iliac Leg Graft

Criteria

Inclusion Criteria:

  • Patient is implanted with Zenith® Spiral-Z® AAA Iliac Leg Graft.

Exclusion Criteria:

  • Patients for whom this device would not normally be considered standard of care.
  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: NCT01540643

  Hide Study Locations
Locations
United States, Alabama
Valley Vascular Consultants Completed
Huntsville, Alabama, United States, 35801
United States, Colorado
University of Colorado, Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Omid Jazaeri, MD    303-724-2690    omid.jazaeri@ucdenver.edu   
United States, Connecticut
Hartford Hospital Recruiting
Hartford, Connecticut, United States, 06102
Contact: Akhilesh Jain    860-471-9895    akhilesh.jain@hhchealth.org   
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Robert Feezor    352-273-7020    Robert.feezor@surgery.ufl.edu   
University of Miami Hospital Completed
Miami, Florida, United States, 33136
United States, Georgia
University Hospital Not yet recruiting
Augusta, Georgia, United States, 30901
Contact: Houman Tamaddon    706-774-7022    hsurg01@gmail.com   
United States, Missouri
Missouri Heart Center Recruiting
Columbia, Missouri, United States, 65201
Contact: Joss Fernandez    573-256-7700    jfernandez@moheartcenter.com   
Mercy Hospital Springfield Completed
Springfield, Missouri, United States, 65804
United States, Montana
St. Vincent's Heart and Vascular Center Not yet recruiting
Billings, Montana, United States, 59101
Contact: Kevin Bruen    352-871-4616    kevin.bruen@sclhs.net   
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Gregory Simonian    201-487-8882    gsimonian@aol.com   
Morristown Medical Center Not yet recruiting
Morristown, New Jersey, United States, 07960
Contact: Amit Patel    973-540-9700    avpatel.ava@verizon.net   
Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08903
Contact: Saum Rahimi, MD       rahimisa@umdnj.edu   
United States, New York
Albany Medical Center Hospital Completed
Albany, New York, United States, 12208
Westchester Medical Center Recruiting
Hawthorne, New York, United States, 10532
Contact: Igor Laskowski, MD    914-593-1200    Laskowskii@wcmc.com   
Mount Sinai Hospital Completed
New York, New York, United States, 10029
United States, North Carolina
Wake Forest Baptist Medical Center Recruiting
Winston-Salem, North Carolina, United States, 25157
Contact: Justin Hurie    336-970-3781    jhurie@wakehealth.edu   
United States, Ohio
Mount Carmel East Completed
Columbus, Ohio, United States, 43213
United States, Oregon
Bend Memorial Clinic Recruiting
Bend, Oregon, United States, 97701
Contact: Wayne Nelson    541-318-3137    drwaynenelson@gmail.com   
United States, Pennsylvania
St. Luke's University Hospital Recruiting
Bethlehem, Pennsylvania, United States, 18045
Contact: Timothy Oskin    610-252-8281    toskin@ppamail.com   
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Michael Singh    412-802-3333    singhmj@upmc.edu   
United States, Tennessee
Physican's Regional Medical Center Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Donald Akers, MD    865-306-5716    dakers@premiersurgical.com   
United States, Texas
Houston VA Recruiting
Houston, Texas, United States, 77030
Contact: Panagiotis Kougias    713-791-1414    pkougias@bcm.edu   
United States, Utah
University of Utah Hospital Not yet recruiting
Salt Lake City, Utah, United States, 84132
Contact: Michelle Mueller    801-581-8301    michelle.mueller@hsc.utah.edu   
United States, Washington
Providence Regional Medical Center Everett Recruiting
Everett, Washington, United States, 98201
Contact: Mark Papenhausen    425-297-5200    mpapenhausen@radiax.com   
United States, West Virginia
Charleston Area Medical Center Recruiting
Charleston, West Virginia, United States, 25304
Contact: Patrick Stone, MD    304-881-2935    pstone0627@yahoo.com   
United States, Wisconsin
Froedert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Cheong Jun Lee    414-805-9160    cjlee@mcw.edu   
Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada, L8L2X2
Contact: John Harlock    905-521-2100    harlock@hhsc.ca   
London Health Sciences Centre Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Thomas Forbes, MD    519-667-6794    tom.forbes@lhsc.on.ca   
Ottawa Hospital Civic Campus Recruiting
Ottawa, Ontario, Canada, K1Y 4E9
Contact: Sudhir Nagpal    613-798-5555    snagpal@ottawahospital.on.ca   
Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Thomas Lindsay, MD    416-340-4800 ext 4620    thomas.lindsay@uhn.ca   
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Thomas Lindsay Toronto General Hospital
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01540643     History of Changes
Other Study ID Numbers: 11-015
Study First Received: February 23, 2012
Last Updated: August 18, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Cook:
abdominal aortic aneurysm
iliac leg graft

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

ClinicalTrials.gov processed this record on October 22, 2014