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 17, 2014
Last verified: July 2014
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
  Hide 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
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
  Hide 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
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  
Number of Participants  
[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  
[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  



  Outcome Measures
  Show All Outcome Measures

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


No publications provided


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 17, 2014
Health Authority: United States: Food and Drug Administration