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Endurant Bifurcated and Aorto-Uni-Iliac (AUI) Stent Graft System

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT00705718
First received: June 24, 2008
Last updated: July 26, 2016
Last verified: July 2016
Results First Received: January 31, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Abdominal Aortic Aneurysms
Intervention: Device: Endurant Stent Graft System

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Endurant AUI Arm Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
Endurant Bifurcated Arm Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair

Participant Flow:   Overall Study
    Endurant AUI Arm   Endurant Bifurcated Arm
STARTED   44   150 
1 Month Follow up   43 [1]   149 [2] 
6 Month Follow up   40 [3]   143 [4] 
12 Month Follow up   37 [5]   128 [6] 
COMPLETED   37   128 
NOT COMPLETED   7   22 
Death                6                6 
Not due for Visit                0                12 
Follow up not done                1                4 
[1] 1 Death
[2] 1 Subject Missed Visit
[3] 3 Deaths
[4] 2 Deaths, 5 Subjects Missed Visit
[5] 2 Deaths
[6] 4 Deaths, 12 Subjects Not due for next visit, 4 Subjects Missed Visit



  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.
No text entered.

Reporting Groups
  Description
Endurant AUI Arm Endurant Stent Graft System : Abdominal Aorto-Uni-Iliac Aneurysm Repair
Endurant Bifurcated Arm Endurant Stent Graft System : Abdominal Aortic Aneurysm Repair
Total Total of all reporting groups

Baseline Measures
   Endurant AUI Arm   Endurant Bifurcated Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 44   150   194 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.8  (7.6)   73.1  (8.0)   73.3  (7.9) 
Gender 
[Units: Participants]
     
Female   14   13   27 
Male   30   137   167 
Region of Enrollment 
[Units: Participants]
     
United States   41   150   191 
Canada   3   0   3 
Baseline Medical History [1] 
[Units: Participants]
     
Angina   11   27   38 
Arrhythmia   15   59   74 
Congestive Heart Failure   7   24   31 
Hypertension   38   130   168 
Myocardial Infarction   14   45   59 
Peripheral vascular disease   33   34   67 
Abnormal renal function   14   43   57 
Chronic obstructive pulmonary disorder   26   53   79 
Diabetes   11   40   51 
Tabacco use in the last 10 years   29   66   95 
[1] The Overall Number of Baseline Participants number may differ from the number within each baseline measure category. The Category number indicates the number of Participants with the baseline measure within that category.


  Outcome Measures
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1.  Primary:   Primary Safety Endpoint (Freedom From MAEs Within 30 Days of Index Procedure)   [ Time Frame: 30 days (Safety) ]

2.  Primary:   Major Adverse Events Within 30 Days of Index Procedure   [ Time Frame: 30 days ]

3.  Primary:   Primary Effectiveness Endpoint (Technical Success)   [ Time Frame: Intra-operatively ]

4.  Primary:   Primary Effectiveness Endpoint (Treatment Success)   [ Time Frame: 12 months ]

5.  Secondary:   Secondary Endpoints - Safety Evaluation   [ Time Frame: 12 months ]

6.  Secondary:   Secondary Endpoint - Effectiveness Evaluation   [ 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
Adverse Events and Serious Adverse Events listed in ClinicalTrials.gov were re-coded, using MeDRA codes. To do so, events were reclassified. As a result, data in listings may not match those in Clinical Update reports, SSEDs, or Instructions for Use.


  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 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: Karla Betz, Principal Clinical Research Specialist
Organization: Medtronic
phone: 763-526-2737
e-mail: karla.h.betz@medtronic.com



Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00705718     History of Changes
Other Study ID Numbers: Medtronic - 089
Study First Received: June 24, 2008
Results First Received: January 31, 2014
Last Updated: July 26, 2016
Health Authority: United States: Food and Drug Administration