Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST)

This study is ongoing, but not recruiting participants.
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 Identifier:
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
Carotid Stenosis
Cerebral Infarction
Myocardial Infarction
Interventions: Procedure: Carotid Endarterectomy (CEA)
Device: Carotid Artery Stenting (CAS)

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
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
  Hide 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
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  
[units: years]
Mean (Standard Deviation)
  68.9  (9.0)     69.2  (8.7)     69.0  (8.9)  
[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  
[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
  Show All Outcome Measures

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
  Hide 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
  Hide More Information

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

Publications of Results:

Other Publications:

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

Responsible Party: Rutgers, The State University of New Jersey 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