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

This study is currently recruiting participants.
Verified March 2013 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01151020
First received: June 22, 2010
Last updated: March 16, 2013
Last verified: March 2013
History of Changes
  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: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • Freedom from major adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Device Success [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Device Success is defined as: graft patency with freedom from aneurysm growth, rupture, conversion to open surgical procedure and endoleak.


Estimated Enrollment: 110
Study Start Date: October 2010
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01151020

Contacts
Contact: Jennifer Gilmore 765-463-7537 jgilmore@medinst.com

  Show 21 Study Locations
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Karl Illig, MD Tampa General Hospital
  More Information

Additional Information:
Click here for more information about thoracic aortic aneurysms (TAA), aortic ulcers, and the Zenith TX2 Low Profile TAA Endovascular Graft Clinical Study.  This link exits the ClinicalTrials.gov site

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: March 16, 2013
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
Ulcer
Vascular Diseases
 Cardiovascular Diseases
Aortic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013