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Protected Carotid Artery Stenting in Subjects at High Risk for Carotid Endarterectomy (CEA) (PROTECT) (PROTECT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00402740
Recruitment Status : Completed
First Posted : November 22, 2006
Results First Posted : June 20, 2012
Last Update Posted : June 20, 2012
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Carotid Artery Disease
Intervention: Device: Xact Stent with either Emboshield Pro (Gen 5) or Emboshield (Gen 3)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 322 subjects were enrolled in the PROTECT study at 38 clinical sites in the United States. The first subject was enrolled on November 29, 2006, and enrollment was completed on June 18, 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Group 1 No text entered.

Participant Flow:   Overall Study
    Group 1
STARTED   322 
COMPLETED   242 
NOT COMPLETED   80 
Withdrawal by Subject                18 
Death                50 
Lost to Follow-up                6 
No stent. Completed FU at 30 days.                5 
Subject disposition unknown.                1 



  Baseline Characteristics

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
Group 1 No text entered.

Baseline Measures
   Group 1 
Overall Participants Analyzed 
[Units: Participants]
 322 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   71 
>=65 years   251 
Age 
[Units: Years]
Mean (Standard Deviation)
 72.7  (9.8) 
Gender 
[Units: Participants]
 
Female   115 
Male   207 
Region of Enrollment 
[Units: Participants]
 
United States   322 


  Outcome Measures

1.  Primary:   Kaplan-Meier Estimate of Freedom From the Composite of Any Death, Stroke and MI During the 30 Day Post Procedural Period (DSMI), Plus Fatal and Non-fatal Ipsilateral Stroke From 31-365 Days and Annually Thereafter for a Total of 3 Years.   [ Time Frame: 3 years ]

2.  Secondary:   Acute Device Success   [ Time Frame: Post-procedure ]

3.  Secondary:   Procedural Success   [ Time Frame: 30 Days ]

4.  Secondary:   Composite of Any Transient Ischemic Attack (TIA) and Amaurosis Fugax   [ Time Frame: ≤30 days ]

5.  Secondary:   Kapan-Meier Estimate of Freedom From Clinically Driven Target Lesion Revascularization Through Three Years.   [ Time Frame: 3 years ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Ellen Travis, MS, NFP
Organization: Abbott Vascular
phone: 408 845-1512
e-mail: Ellen.Travis@av.abbott.com



Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT00402740     History of Changes
Other Study ID Numbers: 640-0071
First Submitted: November 20, 2006
First Posted: November 22, 2006
Results First Submitted: May 7, 2012
Results First Posted: June 20, 2012
Last Update Posted: June 20, 2012