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Carotid Artery Stenting Outcomes in the Standard Risk Population for Carotid Endarterectomy (CANOPY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01445613
First received: September 30, 2011
Last updated: July 13, 2016
Last verified: July 2016
Results First Received: December 3, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Carotid Artery Disease
Stroke
Amaurosis Fugax
Transient Ischemic Attack (TIA)
Intervention: Device: RX Acculink Carotid Stent System (RX Acculink)

  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
Enrollment for the CANOPY clinical trial started on October 11, 2011 and was completed on September 12, 2013. The enrollment goal (1200 subjects) was reached with a total of 1203 subjects enrolled at 97 clinical sites.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
3/1203 subjects who received a non-study stent, were excluded from the analysis. A total of 1200 subjects were included in the primary analysis population (Full analysis set (FAS)).

Reporting Groups
  Description
RX Acculink Carotid Stent System (RX Acculink)

Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.

RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.


Participant Flow for 2 periods

Period 1:   30-day Follow-up
    RX Acculink Carotid Stent System (RX Acculink)
STARTED   1200 
COMPLETED   1165 
NOT COMPLETED   35 
Withdrawal by Subject                6 
Physician Decision                3 
Missed visit                23 
Death                3 

Period 2:   1-year Follow-up
    RX Acculink Carotid Stent System (RX Acculink)
STARTED   1165 
COMPLETED   1088 
NOT COMPLETED   77 
Withdrawal by Subject                12 
Missed visit                29 
Lost to Follow-up                2 
Death                30 
Physician Decision                2 
Received a non-study stent                2 



  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
RX Acculink Carotid Stent System (RX Acculink)

Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.

RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.


Baseline Measures
   RX Acculink Carotid Stent System (RX Acculink) 
Overall Participants Analyzed 
[Units: Participants]
 1200 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.52  (8.46) 
Gender 
[Units: Participants]
 
Female   491 
Male   709 
Race/Ethnicity, Customized 
[Units: Participants]
 
American Indian or Alaska Native   10 
Asian   14 
Black or African Heritage   69 
Native Hawaiian or other Pacific Islander   1 
White   1083 
Hispanic or Latino   30 
Refused to answer   3 
Information not available   3 
Region of Enrollment 
[Units: Participants]
 
United States   1200 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Composite Rate of Peri-procedural (Within 30 Days of the Procedure) Death and Stroke, Plus Ipsilateral Stroke Between Day 31 and 1 Year (365 Days)   [ Time Frame: 0 to 365 days ]

2.  Primary:   Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Between 31 and 365 Days   [ Time Frame: 365 days ]

3.  Secondary:   Death and All Stroke   [ Time Frame: 30 Days ]

4.  Secondary:   Composite of Peri-procedural Death and Stroke by Symptomatic Status   [ Time Frame: 30 days ]

5.  Secondary:   Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Symptomatic Status   [ Time Frame: 365 days ]

6.  Secondary:   Composite of Peri-procedural Death and Stroke by Age   [ Time Frame: 30 days ]

7.  Secondary:   Freedom From Death and Stroke Within 30 Days and Ipsilateral Stroke Through 1 Year by Age   [ Time Frame: 365 days ]

8.  Secondary:   Freedom From Clinically Driven Target Lesion Revascularization   [ Time Frame: 30 days ]

9.  Secondary:   Freedom From Clinically Driven Target Lesion Revascularization   [ Time Frame: 180 days ]

10.  Secondary:   Freedom From Clinically Driven Target Lesion Revascularization   [ Time Frame: 365 days ]

11.  Secondary:   Clinical Success   [ Time Frame: 30 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 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: David R Rutledge
Organization: Abbott Vascular
phone: (408) 845-3820
e-mail: david.rutledge@av.abbott.com



Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01445613     History of Changes
Other Study ID Numbers: 10-720
Study First Received: September 30, 2011
Results First Received: December 3, 2015
Last Updated: July 13, 2016
Health Authority: United States: Institutional Review Board