IRB Number:

841-03

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

This study is being done to compare the results of treating blockages in carotid arteries with either carotid endarterectomy (surgery) OR carotid stent procedure. Carotid endarterectomy is an operation on the carotid artery where the thickened area of the artery is removed through an incision in the neck and is performed under general or local anesthesia. Carotid stenting is a procedure where a metal device called a stent is placed in the narrowed part of the carotid artery to hold it open and is performed under local anesthesia.

The study includes a lead-in phase for credentialing of interventionalists, beyond their initial training and certification requirements.

Who is Eligible to Participate in the Study?

Both males and females from 18 years and above are eligible for the study.

Symptomatic patients with recent neurological events (TIA or non-disabling stroke) with an associated carotid stenosis greater than or equal to 50% by angiography or greater than or equal to 70% by ultrasound are eligible for randomization and participation in this research study.

Asymptomatic patients with no recent (in the last 6 months) neurological events (patients with symptoms beyond 180 days are considered asymptomatic) with an associated carotid stenosis greater than or equal to 60% by angiography or greater than or equal to 70% by ultrasound are eligible for randomization and participation in this research study.
For both symptomatic and asymptomatic patients magnetic resonance angiography (MRA) or computed tomographic angiography (CTA) may also be used to establish eligibility for CREST.

What is Involved With this Study?

In this study, qualified participants will have an equal chance of receiving either the carotid endarterectomy (surgery) or carotid stenting. Neither the participant nor their doctor will know which of the two treatments will be performed until after he or she is randomly assigned (similar to flipping a coin) to one of the two treatments.

• Carotid Endarterectomy
  
  
  Carotid endarterectomy is an operation in which the thickened area (plaque) of the artery is removed through an incision in the neck. Carotid endarterectomy combined with medication is often the standard treatment for some patients with carotid narrowing.
  
  
  
• Carotid Stenting
  
  
  Carotid stenting consists of placing a metal device called a stent in the narrowed part of the artery to hold it open.

  How long will the Study run?

  Follow-up includes clinic visits at 1, 6, and 12 months, then every 6 months for study duration with phone contact every 3 months for up to 4 years.
  

  Who can I Contact for Additional Information on this Trial?

  To participate in this research study or to obtain more information, please call (507) 255-4377 in Rochester, Minnesota or (904) 953-9460 in Jacksonville, Florida or (480) 342-1316 in Phoenix, Arizona.

  What is/are the Locations of this Clinical Trial?

  • Rochester, MN
  • Jacksonville, FL
  • Scottsdale and Phoenix, AZ

  Last updated: 02/07/2008