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Safety and Efficacy Study for Reverse Flow Used During Carotid Artery Stenting Procedure (ROADSTER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Silk Road Medical
ClinicalTrials.gov Identifier:
NCT01685567
First received: September 10, 2012
Last updated: March 3, 2017
Last verified: March 2017
Results First Received: December 20, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Prevention
Condition: Carotid Artery Disease
Intervention: Device: MICHI NPS+f

  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
Recruitment opened November, 2012 and ended March, 2016.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Intention-to-Treat (ITT) All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.

Participant Flow:   Overall Study
    Intention-to-Treat (ITT)
STARTED   219 
COMPLETED   219 
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
Intention-to-Treat (ITT) All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.

Baseline Measures
   Intention-to-Treat (ITT) 
Overall Participants Analyzed 
[Units: Participants]
 219 
Age 
[Units: Years]
Mean (Standard Deviation)
 72.30  (8.574) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      83  37.9% 
Male      136  62.1% 
Symptomatic Status 
[Units: Participants]
Count of Participants
 
Asymptomatic      175  79.9% 
Symptomatic      44  20.1% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Hierarchical Composite of Stroke, Myocardial Infarction, and Death   [ Time Frame: 30-day post-procedure ]

2.  Secondary:   All Death (Non-hierarchical)   [ Time Frame: 0 to 30 days ]

3.  Secondary:   All Myocardial Infarctions (Non-hierarchical)   [ Time Frame: 0 to 30 days ]

4.  Secondary:   All Stroke (Non-hierarchical)   [ Time Frame: 0 to 30 days ]

5.  Secondary:   Ipsilateral Stroke (Non-hierarchical)   [ Time Frame: 31-365 days ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Linda Ruedy. Sr. Director, Clinical and Regulatory Affairs
Organization: Silk Road Medical, Inc.
phone: (408) 585-2113
e-mail: lruedy@silkroadmed.com


Publications of Results:

Responsible Party: Silk Road Medical
ClinicalTrials.gov Identifier: NCT01685567     History of Changes
Other Study ID Numbers: SRM-2012-02
Study First Received: September 10, 2012
Results First Received: December 20, 2016
Last Updated: March 3, 2017