About the 3 Treatment Methods

Participants will be randomly assigned to one of these three treatment methods.

Treatment Method 1
Intensive Medical Management

There are several risk factors for stroke, including high blood pressure, high cholesterol, diabetes, tobacco use, excess body weight, and lack of exercise. These risk factors can be modified through intensive medical management as follows:
  • You will be prescribed a medication, in most cases aspirin, to prevent blood clots and stroke.
  • You will have periodic blood pressure measurements and blood tests.
  • You may be prescribed medication(s) to control your blood pressure and cholesterol levels.
  • If the medications that are prescribed as part of your participation in this study are not covered by your insurance, they may be provided to you by CREST-2 at no cost.
  • You will be enrolled in a risk factor-management program called INTERVENT.
  • You will have a 15- to 20-minute phone call with your INTERVENT coach to assess lifestyle factors such as tobacco use (by far the most important), physical activity, body weight, and alcohol use.
  • You will continue to work with your INTERVENT coach through periodic phone calls to manage these important risk factors for stroke prevention.
  • During the course of the study you will be contacted by your INTERVENT coach:
  • Every two weeks for the first three months
  • Once every three months until your one-year visit
  • Every six months thereafter for up to four years.
For more information regarding INTERVENT, click here: www.INTERVENT.com/CREST-2

Treatment Method 2
Intensive Medical Management and Carotid Endarterectomy

Treatment method 2 involves intensive medical management used in combination with a procedure called carotid endarterectomy (en-dar-ter-EK-ta-mee). Carotid endarterectomy is a surgical procedure to remove the plaque buildup in the carotid artery to prevent stroke. 
Carotid Endarterectomy is performed by:
  • A qualified surgeon using general or local anesthesia 
  • Making an incision in your neck
  • Carefully removing the plaque
  • Restoring blood flow to the brain

Carotid endarterectomy has been the standard of care for the treatment of carotid stenosis for the last 40 years.    
RISKS
With any surgical procedure, there is a risk of complications. Some of the complications that may arise from carotid endarterectomy include: 
  • Discomfort at the site of the surgical incision
  • Damage to blood vessels 
  • Infection
  • Nerve damage
  • Anesthesia complications
  • Stroke
  • Death 

Treatment Method 3
Intensive Medical Management and Carotid Artery Stenting

Treatment method 3 involves intensive medical management used in combination with a procedure called carotid artery stenting. Carotid artery stenting involves using thin, tubular instruments (catheters) that are guided into the carotid artery through a large artery in the groin. A catheter is moved to the narrowed portion of the carotid artery and then typically an umbrella-like filter is opened above the narrowed section of the artery. This filter acts to decrease the chance of cholesterol or other material dislodging, blocking a vessel and causing a stroke. After the filter is opened, a balloon is then inflated to widen the narrowed vessel. Once balloon angioplasty is done, a metallic stent (an expandable mesh tube) is placed at the narrowed site to hold the artery open.
Carotid Artery Stenting is performed by: 
  • A qualified surgeon using local anesthesia
  • Inserting a catheter, usually through the artery near your groin
  • Placing a mesh-like metal device called a stent in the narrowed part of the artery to hold it open 
  • Restoring blood flow to the brain 

Carotid artery stenting has been a common treatment for carotid stenosis for the more than  20 years.     
RISKS
With any surgical procedure, there is a risk of complications. Some of the complications that may arise from carotid stenting include:  
  • Discomfort at the site of surgical incision
  • Damage to blood vessels
  • Blood clots
  • Allergic reaction to X-ray contrast dye
  • Misplacement of the stent
  • Stroke
  • Death