A Study Of INCRAFT™ In Subjects With Abdominal Aortic Aneurysms (INNOVATION)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT01106391
First received: April 16, 2010
Last updated: January 2, 2014
Last verified: January 2014
Results First Received: September 23, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Abdominal Aortic Aneurysms
Intervention: Device: Cordis AAA stent graft system "INCRAFT TM"

  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
There were 60 subjects enrolled in this trial at 7 sites in Germany and Italy from March 19, 2010 to June 20, 2011.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 78 subjects consented and assessed for eligibility, 18 subjects did not meet all study entrance criteria and were considered screen failure.

Reporting Groups
  Description
The INCRAFT™ AAA Stent-graft System The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.

Participant Flow:   Overall Study
    The INCRAFT™ AAA Stent-graft System  
STARTED     60  
COMPLETED     60  
NOT COMPLETED     0  



  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
The INCRAFT™ AAA Stent-graft System The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.

Baseline Measures
    The INCRAFT™ AAA Stent-graft System  
Number of Participants  
[units: participants]
  60  
Age  
[units: years]
Mean ± Standard Deviation
  74.4  ± 6.9  
Gender  
[units: participants]
 
Female     3  
Male     57  
Region of Enrollment  
[units: participants]
 
Germany     31  
Italy     29  
Body mass index  
[units: kg/m²]
Mean ± Standard Deviation
  26.7  ± 3.1  
Diabetes  
[units: participants]
 
Insulin-dependent diabetes     3  
Non-insulin-dependent diabetes     10  
Free of diabetes     47  
Hypertension  
[units: participants]
 
Hypertension     57  
Free of Hypertension     3  



  Outcome Measures
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1.  Primary:   Rate of Technical Success Through the One Month Follow up.   [ Time Frame: From procedure to one month follow up ]

2.  Primary:   Rate of Primary Safety Endpoint Within 1 Month Post-procedure.   [ Time Frame: One month follow-up ]


  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: Amy Berman, Associate Director Clinical Research
Organization: Cordis Corp.
phone: 908-541-4347
e-mail: AOrlick@its.jnj.com


Publications:
Publications automatically indexed to this study:

Responsible Party: Cordis Corporation
ClinicalTrials.gov Identifier: NCT01106391     History of Changes
Other Study ID Numbers: EE09-01
Study First Received: April 16, 2010
Results First Received: September 23, 2013
Last Updated: January 2, 2014
Health Authority: Germany: German Institute of Medical Documentation and Information