TX2® Low Profile TAA Endovascular Graft (TX2® LP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01151020
First received: June 22, 2010
Last updated: February 3, 2014
Last verified: February 2014
  Purpose

The Zenith® TX2® Low Profile TAA Endovascular Graft study is a clinical trial approved by US FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular Graft indicated for the treatment of patients with aneurysms/ulcers of the descending thoracic aorta having vessel structure suitable for repair.


Condition Intervention
Aortic Aneurysm
Penetrating Ulcer
Vascular Disease
Device: Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Freedom from major adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Device Success [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Device Success is defined as: graft patency with freedom from aneurysm growth, rupture, conversion to open surgical procedure and endoleak.


Estimated Enrollment: 170
Study Start Date: October 2010
Estimated Study Completion Date: December 2019
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Device: Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm)
Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
Other Name: TEVAR

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Descending thoracic aneurysm with diameter ≥ 5.0 cm
  • Descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year
  • Descending thoracic degenerative or atherosclerotic ulcer ≥ 10 mm in depth and 20 mm in diameter

Exclusion Criteria:

  • Less than 18 years of age
  • Life expectancy less than 2 years
  • Pregnant or breastfeeding or planning on becoming pregnant within 60 months
  • Unwilling to comply with the follow-up schedule
  • Inability or refusal to give informed consent
  • Less than 30 days beyond primary endpoint for other investigative drug or device study
  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: NCT01151020

Contacts
Contact: Jennifer Gilmore 765-463-7537 jgilmore@medinst.com

  Hide Study Locations
Locations
United States, California
Kaiser Permanente Completed
San Francisco, California, United States, 94115
United States, District of Columbia
Washington Hospital Center Completed
Washington, District of Columbia, United States, 20010
United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33606
Contact: Stephenie Yachanyk, RN    813-259-0921    syapchan@health.usf.edu   
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Ravi Veeraswamy, MD    404-778-4465    ravi_veeraswamy@emoryhealthcare.org   
United States, Indiana
Indiana Heart Hospital Recruiting
Indianapolis, Indiana, United States, 46250
Contact: Gregory Dedinsky, MD    317-621-8500    gdedinsky@ecommunity.com   
Methodist Hospital of Indiana Not yet recruiting
Indianapolis, Indiana, United States, 46202
Contact: Joel Corvera, MD    317-962-5888    jcorvera@iuhealth.org   
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Himanshu Patel, MD    734-936-4478    hjpatel@med.umich.edu   
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Gustavo Oderich, MD    507-225-7208    oderich.gustavo@mayo.edu   
United States, Missouri
Barnes-Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
Contact: Patrick Geraghty, MD    314-362-6490    geraghty@wudosis.wustl.edu   
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Mark Fillinger, MD    603-650-8677    mark.f.fillinger@hitchcock.org   
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Contact: Francis Caputo, MD    856-342-3113    caputo-francis@cooperhealth.edu   
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Susan Mathus, BSN, RN, CCRC    551-996-5722    smathus@hackensackumc.org   
United States, New York
New York University Hospital Completed
New York, New York, United States, 10016
Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Contact: Sharif Ellozy, MD    212-241-3738    sharif.ellozy@mountsinai.org   
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Mark Farber, MD    919-966-3391    farberm@med.unc.edu   
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Chad Hughes, MD    919-668-0903    gchag.hughes@duke.edu   
United States, Ohio
Cleveland Clinic Foundation Completed
Cleveland, Ohio, United States, 44195
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Jean Starr, MD    614-293-8536    jean.starr@osumc.edu   
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Grace Wang, MD    215-614-0308    grace.wang@uphs.upenn.edu   
United States, Tennessee
Tennessee Baptist Memorial Hospital Completed
Memphis, Tennessee, United States, 38120
United States, Virginia
Inova Fairfax Hospital Completed
Falls Church, Virginia, United States, 22042
United States, Washington
Harborview Medical Center Completed
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Karl Illig, MD Tampa General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01151020     History of Changes
Other Study ID Numbers: 10-001
Study First Received: June 22, 2010
Last Updated: February 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Cook:
Aortic Aneurysm
Aneurysm
Vascular Prosthesis
Vascular Disease
Blood Vessel Prosthesis Implantation

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Ulcer
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 28, 2014