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

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ClinicalTrials.gov Identifier: NCT01151020
Recruitment Status : Active, not recruiting
First Posted : June 25, 2010
Results First Posted : February 29, 2016
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated ( Cook Research Incorporated )

Brief Summary:
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 or disease Intervention/treatment Phase
Aortic Aneurysm Penetrating Ulcer Vascular Disease Device: Zenith® TX2® Low Profile TAA Endovascular Graft Not Applicable

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study
Study Start Date : March 2010
Actual Primary Completion Date : January 2014
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Experimental: Arm 1
Zenith® TX2® Low Profile TAA Endovascular Graft (Thoracic Aortic Aneurysm)
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




Primary Outcome Measures :
  1. Patients With Major Adverse Events (MAE) [ Time Frame: 30 days ]

    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.


  2. Patients With Device Failures [ Time Frame: 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01151020


  Show 33 Study Locations
Sponsors and Collaborators
Cook Research Incorporated
Investigators
Principal Investigator: Karl Illig, MD University of South Florida

Additional Information:
Responsible Party: Cook Research Incorporated
ClinicalTrials.gov Identifier: NCT01151020     History of Changes
Obsolete Identifiers: NCT00923754
Other Study ID Numbers: 10-001
First Posted: June 25, 2010    Key Record Dates
Results First Posted: February 29, 2016
Last Update Posted: May 8, 2018
Last Verified: April 2018

Keywords provided by Cook Group Incorporated ( Cook Research Incorporated ):
Aortic Aneurysm
Aneurysm
Vascular Prosthesis
Vascular Disease
Blood Vessel Prosthesis Implantation

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases