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Zenith® TX2® Low Profile TAA Endovascular Graft

Primary Purpose

Aortic Aneurysm, Penetrating Ulcer, Vascular Disease

Status
Approved for marketing
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Zenith TX2 Low Profile TAA Endovascular Graft
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Aortic Aneurysm focused on measuring Aortic Aneurysm, Aneurysm, Vascular Prosthesis, Vascular Disease, Blood Vessel Prosthesis Implantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Florida
  • Emory University
  • Methodist Hospital of Indiana
  • Indiana Heart Hospital
  • University of Michigan Health System
  • Mayo Clinic
  • Barnes-Jewish Hospital
  • Dartmouth Hitchcock Medical Center
  • Cooper University Hospital
  • Hackensack University Medical Center
  • The Mount Sinai Hospital
  • University of North Carolina
  • Duke University Medical Center
  • Ohio State University
  • Hospital of the University of Pennsylvania

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 11, 2015
Last Updated
January 15, 2020
Sponsor
Cook Group Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02471781
Brief Title
Zenith® TX2® Low Profile TAA Endovascular Graft
Official Title
Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study
Study Type
Expanded Access

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Approved for marketing
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Penetrating Ulcer, Vascular Disease
Keywords
Aortic Aneurysm, Aneurysm, Vascular Prosthesis, Vascular Disease, Blood Vessel Prosthesis Implantation

7. Study Design

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Illig, MD
Organizational Affiliation
Dialysis Access Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Methodist Hospital of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Indiana Heart Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46250
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Cooper University Hospital
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
The Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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Zenith® TX2® Low Profile TAA Endovascular Graft

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