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
Results First Received: October 16, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Aortic Aneurysm
Penetrating Ulcer
Vascular Disease
Intervention: Device: Zenith® TX2® Low Profile TAA Endovascular Graft

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Zenith® TX2® Low Profile TAA Endovascular Graft  
STARTED     110  
30-day     110  
12-month     99  
COMPLETED     0  
NOT COMPLETED     110  
Death                 15  
Conversion to open repair                 1  
Lost to Follow-up                 1  
Withdrawal by Subject                 12  
Patients did not receive the device                 2  
Still be eligible for follow-up                 79  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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

Baseline Measures
    Zenith® TX2® Low Profile TAA Endovascular Graft  
Number of Participants  
[units: participants]
  110  
Age  
[units: years]
Mean (Standard Deviation)
  72.2  (9.8)  
Gender  
[units: participants]
 
Female     46  
Male     64  



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

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Scott Snyder, PhD, Director of Clinical Science & Biostatistics
Organization: Cook Research Incorporated
phone: 765-463-7537
e-mail: SSnyder@medinst.com



Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01151020     History of Changes
Obsolete Identifiers: NCT00923754
Other Study ID Numbers: 10-001
Study First Received: June 22, 2010
Results First Received: October 16, 2015
Last Updated: March 16, 2016
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: Ministry of Health
Sweden: Medical Products Agency