Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Alabama at Birmingham
Rutgers, The State University of New Jersey
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00004732
First received: February 25, 2000
Last updated: March 14, 2014
Last verified: September 2013
Results First Received: September 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   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
No text entered.

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  
Number of Participants  
[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


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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.


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.  


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:


Responsible Party: Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier: NCT00004732     History of Changes
Other Study ID Numbers: 0119970017, R01NS038384
Study First Received: February 25, 2000
Results First Received: September 26, 2013
Last Updated: March 14, 2014
Health Authority: United States: Food and Drug Administration
United States: Data and Safety Monitoring Board
United States: Institutional Review Board
Canada: Health Canada