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

January 4, 2021 updated by: Cook Research Incorporated

Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany
        • Hannover Medical School
      • Munster, Germany
        • St. Franziskus Hospital
      • Nürnberg, Germany, 90471
        • Klinikum Nürnberg Süd
      • Regensburg, Germany
        • Uniklinik Regensburg
      • Rostock, Germany, 18057
        • University Hospital Rostock
  • Italy
      • Milan, Italy, 20132
        • Hospital San Raffaele
  • Japan
      • Osaka, Japan
        • Morinomiya Hospital
      • Tokyo, Japan, 160-8582
        • Keio University Hospital
      • Tokyo, Japan, 105-8461
        • Jikei University School of Medicine
  • Sweden
      • Malmö, Sweden
        • Malmö University Hospital
  • United Kingdom
      • London, United Kingdom, SW 17 0QT
        • St.George's Hospital
  • United States
    • California
      • San Francisco, California, United States, 94115
        • Kaiser Permanente
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Washington Hospital Center
    • Florida
      • Tampa, Florida, United States, 33606
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Methodist Hospital of Indiana
      • Indianapolis, Indiana, United States, 46250
        • Indiana Heart Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper University Hospital
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • New York, New York, United States, 10016
        • New York University Hospital
      • New York, New York, United States, 10029
        • Mount Sinai Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Tennessee Baptist Memorial Hospital
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Hospital
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm)
Device: Zenith® TX2® Low Profile TAA Endovascular Graft
Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
Other Names:
  • Zenith Alpha Thoracic™ Endovascular Graft
  • TEVAR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients With Major Adverse Events (MAE)
Time Frame: 30 days

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.
30 days
Patients With Device Failures
Time Frame: 12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook Research Incorporated

Investigators

  • Principal Investigator: Karl Illig, MD, University of South Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

May 11, 2018

Study Registration Dates

First Submitted

June 22, 2010

First Submitted That Met QC Criteria

June 24, 2010

First Posted (Estimate)

June 25, 2010

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 4, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aortic Aneurysm

Clinical Trials on Zenith® TX2® Low Profile TAA Endovascular Graft

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe