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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01151020
First received: June 22, 2010
Last updated: March 16, 2016
Last verified: March 2016

June 22, 2010
March 16, 2016
March 2010
January 2014   (final data collection date for primary outcome measure)
  • Patients With Major Adverse Events (MAE) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

    Major adverse event is defined as:

    All-cause death; Q-wave MI; cardiac event involving arrest, resuscitation, or balloon pump; ventilation > 72 hours or re-intubation; pulmonary event requiring tracheostomy or chest tube; renal failure requiring permanent dialysis, hemofiltration, or kidney transplant in a patient with a normal pre-procedure serum creatinine level; bowel resection; stroke; paralysis; amputation involving more than toes; aneurysm or vessel leak requiring re-operation; deep vein thrombosis requiring surgical or lytic therapy; pulmonary embolism involving hemodynamic instability or surgery; coagulopathy requiring surgery; or wound complication requiring return to the operating room.

  • Patients With Device Failures [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Device failure is defined as: Technical failure (inability to access or deploy the Zenith® TX2® Low Profile TAA Endovascular Graft or loss of patency at the time of deployment completion), or any of the following: type I or type III endoleaks requiring re-intervention, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm.
Freedom from major adverse events [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01151020 on ClinicalTrials.gov Archive Site
Not Provided
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.
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
Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
Other Names:
  • Zenith Alpha Thoracic™ Endovascular Graft
  • TEVAR
Experimental: Arm 1
Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm)
Intervention: Device: Zenith® TX2® Low Profile TAA 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
110
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 information is only displayed when the study is recruiting subjects
United States,   Germany,   Italy,   Japan,   Sweden,   United Kingdom
 
NCT01151020
10-001
Not Provided
Not Provided
Not Provided
Cook
Cook
Not Provided
Principal Investigator: Karl Illig, MD University of South Florida
Cook
March 2016

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