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

Primary Purpose

Aortic Aneurysm, Penetrating Ulcer, Vascular Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Zenith® TX2® Low Profile TAA Endovascular Graft
Sponsored by
Cook Research Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment 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:

  • 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

Sites / Locations

  • Kaiser Permanente
  • Washington Hospital Center
  • University of South Florida
  • Emory University
  • Methodist Hospital of Indiana
  • Indiana Heart Hospital
  • University of Michigan
  • Mayo Clinic Rochester
  • Barnes-Jewish Hospital
  • Dartmouth Hitchcock Medical Center
  • Cooper University Hospital
  • Hackensack University Medical Center
  • New York University Hospital
  • Mount Sinai Hospital
  • University of North Carolina
  • Duke University Medical Center
  • Cleveland Clinic Foundation
  • Ohio State University
  • Hospital of the University of Pennsylvania
  • Tennessee Baptist Memorial Hospital
  • Inova Fairfax Hospital
  • Harborview Medical Center
  • Hannover Medical School
  • St. Franziskus Hospital
  • Klinikum Nürnberg Sud
  • Uniklinik Regensburg
  • University Hospital Rostock
  • Hospital San Raffaele
  • Morinomiya Hospital
  • Jikei University School of Medicine
  • Keio University Hospital
  • Malmö University Hospital
  • St.George's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm)

Outcomes

Primary Outcome Measures

Patients With Major Adverse Events (MAE)
Major adverse event is defined as: All-cause death; Q-wave MI; cardiac event involving arrest, resuscitation, or balloon pump; ventilation > 72 hours or re-intubation; pulmonary event requiring tracheostomy or chest tube; renal failure requiring permanent dialysis, hemofiltration, or kidney transplant in a patient with a normal pre-procedure serum creatinine level; bowel resection; stroke; paralysis; amputation involving more than toes; aneurysm or vessel leak requiring re-operation; deep vein thrombosis requiring surgical or lytic therapy; pulmonary embolism involving hemodynamic instability or surgery; coagulopathy requiring surgery; or wound complication requiring return to the operating room.
Patients With Device Failures
Device failure is defined as: Technical failure (inability to access or deploy the Zenith® TX2® Low Profile TAA Endovascular Graft or loss of patency at the time of deployment completion), or any of the following: type I or type III endoleaks requiring re-intervention, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm.

Secondary Outcome Measures

Full Information

First Posted
June 22, 2010
Last Updated
January 4, 2021
Sponsor
Cook Research Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01151020
Brief Title
TX2® Low Profile TAA Endovascular Graft
Acronym
TX2® LP
Official Title
Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
May 11, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
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.

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

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm)
Intervention Type
Device
Intervention Name(s)
Zenith® TX2® Low Profile TAA Endovascular Graft
Other Intervention Name(s)
Zenith Alpha Thoracic™ Endovascular Graft, TEVAR
Intervention Description
Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
Primary Outcome Measure Information:
Title
Patients With Major Adverse Events (MAE)
Description
Major adverse event is defined as: All-cause death; Q-wave MI; cardiac event involving arrest, resuscitation, or balloon pump; ventilation > 72 hours or re-intubation; pulmonary event requiring tracheostomy or chest tube; renal failure requiring permanent dialysis, hemofiltration, or kidney transplant in a patient with a normal pre-procedure serum creatinine level; bowel resection; stroke; paralysis; amputation involving more than toes; aneurysm or vessel leak requiring re-operation; deep vein thrombosis requiring surgical or lytic therapy; pulmonary embolism involving hemodynamic instability or surgery; coagulopathy requiring surgery; or wound complication requiring return to the operating room.
Time Frame
30 days
Title
Patients With Device Failures
Description
Device failure is defined as: Technical failure (inability to access or deploy the Zenith® TX2® Low Profile TAA Endovascular Graft or loss of patency at the time of deployment completion), or any of the following: type I or type III endoleaks requiring re-intervention, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Illig, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
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
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic Rochester
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
New York University Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
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
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
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
Facility Name
Tennessee Baptist Memorial Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Hannover Medical School
City
Hannover
Country
Germany
Facility Name
St. Franziskus Hospital
City
Munster
Country
Germany
Facility Name
Klinikum Nürnberg Sud
City
Nürnberg
ZIP/Postal Code
90471
Country
Germany
Facility Name
Uniklinik Regensburg
City
Regensburg
Country
Germany
Facility Name
University Hospital Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
Hospital San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Facility Name
Morinomiya Hospital
City
Osaka
Country
Japan
Facility Name
Jikei University School of Medicine
City
Tokyo
ZIP/Postal Code
105-8461
Country
Japan
Facility Name
Keio University Hospital
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Malmö University Hospital
City
Malmö
Country
Sweden
Facility Name
St.George's Hospital
City
London
ZIP/Postal Code
SW 17 0QT
Country
United Kingdom

12. IPD Sharing Statement

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TX2® Low Profile TAA Endovascular Graft

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