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Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease (ACT I)

This study has been terminated.
(Business decision and not a result of any patient or product safety issues.)
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT00106938
First received: April 1, 2005
Last updated: October 13, 2014
Last verified: October 2014
Results First Received: April 2, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label
Conditions: Carotid Artery Disease
Carotid Stenosis
Stroke
Atherosclerosis
Interventions: Device: Carotid artery stenting with filter (interventional)
Procedure: Carotid artery endarterectomy (surgical)

  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
Asymptomatic subjects with extracranial internal carotid stenosis which was ≥70% & ≤99% by duplex ultrasound or ≥70% & ≤99% by angiography (visual estimate) with or without involvement of the contiguous common carotid artery, who could undergo carotid artery stenting/carotid endarterectomy and all follow-ups, were recruited starting from April 2005

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1453 patients were randomized to support the primary analysis; an additional 210 lead-in subjects were enrolled to allow investigators to gain experience with the study devices prior to randomizing subjects and were not part of the primary analysis.

Reporting Groups
  Description
CAS Group

CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).

Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

CEA Group

CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).

Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.


Participant Flow:   Overall Study
    CAS Group     CEA Group  
STARTED     1089     364  
COMPLETED     913     293  
NOT COMPLETED     176     71  



  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
CAS Group

CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).

Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

CEA Group

CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).

Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years.

Total Total of all reporting groups

Baseline Measures
    CAS Group     CEA Group     Total  
Number of Participants  
[units: participants]
  1089     364     1453  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     325     103     428  
>=65 years     764     261     1025  
Age  
[units: years]
Mean ± Standard Deviation
  67.7  ± 7.0     67.9  ± 6.9     67.7  ± 7.0  
Gender  
[units: participants]
     
Female     423     157     580  
Male     666     207     873  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     985     327     1312  
Hispanic or Latino     38     12     50  
Pacific Islander     0     1     1  
Black or African American     45     16     61  
American Indian or Alaska     1     0     1  
Asian     10     4     14  
Other     10     4     14  
Region of Enrollment  
[units: participants]
     
United States     1089     364     1453  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Composite of Any Death, Stroke, and Myocardial Infarction (MI) Within 30 Days Post-index Procedure   [ Time Frame: 0 to 30 days ]

2.  Primary:   Composite of Any Death, Stroke, and MI Within 30 Days and Ipsilateral Stroke 31 Days to 365 Days   [ Time Frame: 0 to 365 days ]

3.  Secondary:   Acute Device Success: Xact Stent   [ Time Frame: 0 to 30 days post procedure ]

4.  Secondary:   Acute Device Success: Embolic Protection Device System   [ Time Frame: 0 to 30 days post procedure ]

5.  Secondary:   Procedural Success   [ Time Frame: 0 to 30 days post procedure ]

6.  Secondary:   Composite Morbidity Measure   [ Time Frame: 0 to 30 Days Post-procedure ]

7.  Secondary:   Freedom From Clinically Indicated Target Lesion Revascularization   [ Time Frame: 0 to 180 days ]

8.  Secondary:   Freedom From Clinically Indicated Target Lesion Revascularization   [ Time Frame: 0 to 365 days ]

9.  Secondary:   Freedom From Clinically Indicated Target Lesion Revascularization   [ Time Frame: 0 to 730 days ]

10.  Secondary:   Freedom From Clinically Indicated Target Lesion Revascularization   [ Time Frame: 0 to 1095 days ]

11.  Secondary:   Freedom From Clinically Indicated Target Lesion Revascularization   [ Time Frame: 0 to 1460 days ]

12.  Secondary:   Freedom From Clinically Indicated Target Lesion Revascularization   [ Time Frame: 0 to 1825 days ]

13.  Secondary:   Freedom From Ipsilateral Stroke   [ Time Frame: 31 to 365 days ]

14.  Secondary:   Freedom From Ipsilateral Stroke   [ Time Frame: 31 to 730 days ]

15.  Secondary:   Freedom From Ipsilateral Stroke   [ Time Frame: 31 to 1095 days ]

16.  Secondary:   Freedom From Ipsilateral Stroke   [ Time Frame: 31 to 1460 days ]

17.  Secondary:   Freedom From Ipsilateral Stroke   [ Time Frame: 31 to 1825 days ]

18.  Secondary:   Freedom From Mortality   [ Time Frame: 0 to 365 days ]

19.  Secondary:   Freedom From Mortality   [ Time Frame: 0 to 730 days ]

20.  Secondary:   Freedom From Mortality   [ Time Frame: 0 to 1095 days ]

21.  Secondary:   Freedom From Mortality   [ Time Frame: 0 to 1460 days ]

22.  Secondary:   Freedom From Mortality   [ Time Frame: 0 to 1825 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: Jennifer M Jones-McMeans, PhD (Associate Director Clinical Research)
Organization: Abbott Vascular
phone: 408-845-1459
e-mail: jennifer.jones@av.abbott.com


No publications provided


Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00106938     History of Changes
Other Study ID Numbers: AVD-640-0052
Study First Received: April 1, 2005
Results First Received: April 2, 2014
Last Updated: October 13, 2014
Health Authority: United States: Food and Drug Administration