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

This study is currently recruiting participants. (see Contacts and Locations)
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

June 22, 2010
February 3, 2014
October 2010
January 2014   (final data collection date for primary outcome measure)
Freedom from major adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01151020 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
TX2® Low Profile TAA Endovascular Graft
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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Aortic Aneurysm
  • Penetrating Ulcer
  • Vascular Disease
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
Experimental: Arm 1
Intervention: Device: Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
170
December 2019
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jennifer Gilmore 765-463-7537 jgilmore@medinst.com
United States
 
NCT01151020
10-001
Not Provided
Cook
Cook
Not Provided
Principal Investigator: Karl Illig, MD Tampa General Hospital
Cook
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP