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

Expanded access is currently available for this treatment.
Verified August 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01151020
First received: June 22, 2010
Last updated: August 20, 2014
Last verified: August 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: Expanded Access     What is Expanded Access?
Official Title: Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study

Resource links provided by NLM:


Further study details as provided by Cook:

Study Start Date: October 2010
Estimated Study Completion Date: December 2019
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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

  Show 25 Study Locations
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Karl Illig, MD University of South Florida
  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: August 20, 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
Vascular Diseases
Aortic Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014