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Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
University of Alabama at Birmingham
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00004732
First received: February 25, 2000
Last updated: January 4, 2016
Last verified: October 2015
Results First Received: September 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Atherosclerosis
Stroke
Carotid Stenosis
Cerebral Infarction
Myocardial Infarction
Interventions: Procedure: Carotid Endarterectomy (CEA)
Device: Carotid Artery Stenting (CAS)

  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
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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
Carotid-Artery Stenting (CAS) CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. The stent is then placed to cover the plaque and hold the artery open.
Carotid Endarterectomy (CEA) CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.

Participant Flow:   Overall Study
    Carotid-Artery Stenting (CAS)   Carotid Endarterectomy (CEA)
STARTED   1262   1240 
COMPLETED   1193   1129 
NOT COMPLETED   69   111 
Withdrawal by Subject                36                64 
Lost to Follow-up                33                47 



  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.
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Reporting Groups
  Description
Carotid-Artery Stenting Patients Randomized to CAS
Carotid Endarterectomy Patients Randomized to CEA
Total Total of all reporting groups

Baseline Measures
   Carotid-Artery Stenting   Carotid Endarterectomy   Total 
Overall Participants Analyzed 
[Units: Participants]
 1262   1240   2502 
Age 
[Units: Years]
Mean (Standard Deviation)
 68.9  (9.0)   69.2  (8.7)   69.0  (8.9) 
Gender 
[Units: Participants]
     
Female   455   417   872 
Male   807   823   1630 
Race/Ethnicity, Customized 
[Units: Participants]
     
White   1172   1160   2332 
Non-White   81   71   152 
Not Specified   9   9   18 
Symptomatic Status 
[Units: Participants]
     
Asymptomatic   594   587   1181 
Symptomatic   668   653   1321 
Baseline Hypertension 
[Units: Participants]
     
Yes   1080   1061   2141 
No   179   172   351 
Unknown   3   7   10 
Diabetes Status 
[Units: Participants]
     
Yes   384   375   759 
No   873   857   1730 
Unknown   5   8   13 
Dyslipidemia 
[Units: Participants]
     
Yes   1040   1053   2093 
No   214   174   388 
Unknown   8   13   21 
Present Smoker 
[Units: Participant]
     
Yes   329   317   646 
No   915   899   1814 
Unknown   18   24   42 
Lesion Location 
[Units: Participants]
     
Left   639   648   1287 
Right   623   592   1215 
Systolic Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 141.6  (20.2)   141.2  (20.5)   141.4  (20.3) 
Diastolic Blood Pressure 
[Units: mmHg]
Mean (Standard Deviation)
 74.0  (11.6)   73.9  (11.5)   74.0  (11.5) 
Percent Stenosis at Randomization 
[Units: Participants]
     
Moderate (<70%)   165   186   351 
Severe (>=70%)   1097   1054   2151 


  Outcome Measures
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1.  Primary:   Any Periprocedural Stroke, Myocardial Infarction, or Death or Postprocedural Ipsilateral Stroke   [ Time Frame: 4 years ]

2.  Secondary:   Differential Efficacy of CAS and CEA in Male and Female Participants in the Primary Endpoint (Any Periprocedural Stroke, Myocardial Infarction, or Death or Postprocedural Ipsilateral Stroke).   [ Time Frame: 4 years ]


  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: Thomas G. Brott, MD - Principal Investigator
Organization: Mayo Clinic
phone: 904-953-0556
e-mail: Brott.thomas@mayo.edu


Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier: NCT00004732     History of Changes
Other Study ID Numbers: 0119970017
R01NS038384 ( US NIH Grant/Contract Award Number )
Study First Received: February 25, 2000
Results First Received: September 26, 2013
Last Updated: January 4, 2016
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board
Canada: Health Canada
United States: Food and Drug Administration