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Post-Approval Trial of the Talent™ Abdominal Stent Graft to Treat Aortic Aneurysms (VITALITY)

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ClinicalTrials.gov Identifier: NCT00816062
Recruitment Status : Completed
First Posted : December 31, 2008
Results First Posted : January 23, 2018
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Aortic Aneurysm, Abdominal
Intervention: Device: Talent Abdominal Stent Graft

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
166 subjects were enrolled in the previous cohort study (NCT # is not available). 94 subjects were enrolled into the Vitality study. When these two cohorts are combined it totals 260. The Vitality study collected information on its 94 enrolled subjects, but for study analysis both cohorts were combined.

Reporting Groups
  Description
Talent Abdominal Stent Graft

Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the Food and Drug Administration (FDA) approved Instructions for Use (IFU).

>

> Talent Abdominal Stent Graft: The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement.


Participant Flow:   Overall Study
    Talent Abdominal Stent Graft
STARTED   260 
COMPLETED   133 
NOT COMPLETED   127 



  Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Treatment

Patients diagnosed with an abdominal aortic or aorto-iliac aneurysm that are considered candidates for endovascular repair, per the FDA approved IFU. >

> Talent Abdominal Stent Graft: The Talent Abdominal Stent Graft is indicated for the endovascular treatment of abdominal aortic aneurysms with or without iliac involvement.


Baseline Measures
   Treatment 
Overall Participants Analyzed 
[Units: Participants]
 260 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.7  (7.9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      33  12.7% 
Male      227  87.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      6   2.3% 
Not Hispanic or Latino      254  97.7% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      5   1.9% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      9   3.5% 
White      241  92.7% 
More than one race      5   1.9% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   260 


  Outcome Measures

1.  Primary:   Freedom From Aneurysm-related Mortality (ARM)   [ Time Frame: 5 year Kaplan Meier (KM) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Rianna Rapson
Organization: Medtronic
phone: 7635262170
e-mail: rianna.k.rapson@medtronic.com



Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00816062     History of Changes
Other Study ID Numbers: P070027/S002
First Submitted: December 29, 2008
First Posted: December 31, 2008
Results First Submitted: August 1, 2016
Results First Posted: January 23, 2018
Last Update Posted: March 15, 2018