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Zenith® TX2® Low Profile TAA Endovascular Graft

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02471781
Expanded Access Status : Approved for marketing
First Posted : June 15, 2015
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

Brief Summary:
The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is indicated for the treatment of patients with a descending thoracic aortic aneurysm or penetrating ulcer and has an anatomy suitable for repair.

Condition or disease Intervention/treatment
Aortic Aneurysm Penetrating Ulcer Vascular Disease Device: Zenith TX2 Low Profile TAA Endovascular Graft

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Study Type : Expanded Access
  See clinical trials of the intervention/treatment in this expanded access record.
Official Title: Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms


Intervention Details:
  • Device: Zenith TX2 Low Profile TAA Endovascular Graft
    Endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having morphology suitable for endovascular repair.
    Other Name: Zenith Alpha Thoracic™ Endovascular Graft

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets one of the following

    • 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:

  • Life expectancy less than 2 years
  • Pregnant of breastfeeding or planning on becoming pregnant within 60 months
  • Unwilling to comply with the follow-up schedule
  • Less than 30 days beyond primary endpoint for other investigative drug or device study
  • Receiving home oxygen
  • Myocardial infarction within the last 3 months
  • Stroke within the last 3 months
  • Diagnosed or suspected congenital degenerative collagen disease
  • Systemic infection
  • Bleeding diathesis, uncorrectable coagulopathy, or refuses blood transfusion
  • Allergy to polyester, polypropylene, nitinol, or gold
  • Previous placement of a thoracic endovascular graft
  • Prior open repair involving the descending thoracic aorta

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02471781


Locations
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United States, Florida
University of South Florida
Tampa, Florida, United States, 33606
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Indiana
Methodist Hospital of Indiana
Indianapolis, Indiana, United States, 46202
Indiana Heart Hospital
Indianapolis, Indiana, United States, 46250
United States, Michigan
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
The Mount Sinai Hospital
New York, New York, United States, 10029
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Cook Group Incorporated
Investigators
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Principal Investigator: Karl Illig, MD Dialysis Access Center
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Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT02471781    
Obsolete Identifiers: NCT02319551
Other Study ID Numbers: 10-001 CA
First Posted: June 15, 2015    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Keywords provided by Cook Group Incorporated:
Aortic Aneurysm
Aneurysm
Vascular Prosthesis
Vascular Disease
Blood Vessel Prosthesis Implantation
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases