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

This study is currently recruiting participants.
Verified February 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01151020
First received: June 22, 2010
Last updated: February 3, 2014
Last verified: February 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: 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:


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: 170
Study Start Date: October 2010
Estimated Study Completion Date: December 2019
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 22 Study Locations
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Karl Illig, MD Tampa General Hospital
  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: February 3, 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
Ulcer
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014