Effects of Carotid Stent Design on Cerebral Embolization

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carlos H. Timaran, Dallas VA Medical Center
ClinicalTrials.gov Identifier:
NCT00830232
First received: January 26, 2009
Last updated: February 10, 2014
Last verified: February 2014
Results First Received: March 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Stroke
Carotid Stenosis
Interventions: Device: closed-cell stent
Device: Open-cell stent

  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
Patients recruitment was started on december 2008 and continued until February 2012. Patients recruitment and consenting were performed at the medical clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were considered officially enrolled after the randomization, which was performed during the procedure after the initial angiography (initial image of the brain blood flow).

Reporting Groups
  Description
Closed-cell Stent

Patients enrolled in this study arm underwent for carotid stenting using closed stent cell. The graft used in this group was the Xact closed-cell stent. This type of device is a rigid device with a dense composition between the nitinol rings.

Carotid stenting was used on standard fashion using filters as embolic protection device.

Open-cell Stent

Patients enrolled in this study arm underwent for carotid stenting using open stent cell stents. This type of stent is a tube shaped graft composed of flexible nitinol rings. The device used in this group was the Acculinx open-cell stent.

Stenting procedure eas performed on standard fashion.Filters were used as embolic protection device.


Participant Flow:   Overall Study
    Closed-cell Stent     Open-cell Stent  
STARTED     20     20  
COMPLETED     20     20  
NOT COMPLETED     0     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
Closed-cell Stent closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
Open-cell Stent Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
Total Total of all reporting groups

Baseline Measures
    Closed-cell Stent     Open-cell Stent     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     7     5     12  
>=65 years     13     15     28  
Age  
[units: years]
Mean ± Standard Deviation
  66  ± 8.07     67  ± 8.5     66.7  ± 8.2  
Gender  
[units: participants]
     
Female     3     1     4  
Male     17     19     36  
Region of Enrollment  
[units: participants]
     
United States     20     20     40  



  Outcome Measures

1.  Primary:   Transcranial Doppler Counts of Micro-embolic Signals in the Ipsilateral Middle Cerebral Artery.   [ Time Frame: First 24 hours after implantation of carotid stent ]

2.  Secondary:   Composite of Any Stroke, Myocardial Infarction or Death   [ Time Frame: within 30 days after the carotid stenting procedure ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Subclinical Cerebral Embolization Assessed by Brain Diffusion-weighted MRI   [ Time Frame: within 24 hours after carotid artery stenting ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  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
1. Small sample size 2.randomization did not eliminate all pretreatment differences between groups because of the small sample size.3.All patients underwent Stenting under filter embolic protection.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Carlos H Timaran
Organization: Dallas VA Medical Center
phone: 2148570336
e-mail: carlos.timaran@va.gov


No publications provided by Dallas VA Medical Center

Publications automatically indexed to this study:

Responsible Party: Carlos H. Timaran, Dallas VA Medical Center
ClinicalTrials.gov Identifier: NCT00830232     History of Changes
Other Study ID Numbers: IRB#08-035
Study First Received: January 26, 2009
Results First Received: March 8, 2013
Last Updated: February 10, 2014
Health Authority: United States: Federal Government