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Zenith TX2-Low-Profile (LP) Clinical Study (TX2-LP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00923754
First received: June 16, 2009
Last updated: August 18, 2014
Last verified: August 2014

June 16, 2009
August 18, 2014
March 2010
March 2013   (final data collection date for primary outcome measure)
Deployment and procedural success [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00923754 on ClinicalTrials.gov Archive Site
Thoracic aortic aneurysm-related mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Zenith TX2-Low-Profile (LP) Clinical Study
Zenith TX2® TAA Low-Profile Endovascular Graft Clinical Study

The Zenith TX2-LP Clinical Study is a small, early clinical experience trial approved by the German (BfArM), Swedish (Läkemedelsverket), British (MHRA) and Italian (MoH) authorities to study the safety and effectiveness of the Zenith TX2® TAA Low-Profile Endovascular Graft in the treatment of thoracic aortic aneurysms in Germany, Sweden, Britain and Italy.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Descending Thoracic Aortic Aneurysm
Device: Zenith TX2(R) TAA Low-Profile Endovascular Graft
Endovascular treatment with the study device
Other Name: TEVAR
Experimental: Endovascular Repair
Treatment Arm
Intervention: Device: Zenith TX2(R) TAA Low-Profile Endovascular Graft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
17
March 2018
March 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Descending thoracic aortic aneurysm with diameter ≥ 5.0 cm; or
  • Descending thoracic aortic aneurysm with a history of growth ≥ 0.5 cm within the previous 12 months; or
  • Descending thoracic aortic degenerative or atherosclerotic ulcers ≥ 10 mm in depth and 20 mm in diameter

Exclusion Criteria:

  • Age < 18 years
  • Other medical condition that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., less than 2 years)
  • Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
  • Unwilling or unable to comply with the follow-up schedule
  • Inability or refusal to give informed consent
  • Less than 30 days beyond primary endpoint in another investigative device or drug study
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   Sweden,   United Kingdom
 
NCT00923754
08-017, 430030, TXLP
Not Provided
Cook
Cook
Not Provided
Not Provided
Cook
August 2014

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