Patients and Public

ACT I Study Overview

The ACT I study is designed to explore alternative procedures for the management of carotid artery disease—a major risk factor for stroke. Stroke is the third leading cause of death and the leading cause of disability in the United States.1

Purpose

The purpose of the ACT I study is to find out if stenting is as effective as surgery in the benefits it provides for patients who are at standard risk for surgery. The study will compare the standard surgical treatment to carotid stenting.

Study design

The ACT I study will involve at least 50 hospitals across the US.

  • Approximately 2,058 patients will be enrolled
  • All eligible patients will receive treatment for their severe carotid artery disease
  • Patients will be chosen at random to receive either the carotid stent or surgical treatment; about three-fourths will receive a stent
  • After treatment, participants will have follow-up exams at 30 days, 6 months, and 12 months, then annually up to 5 years
Who can participate?

Both men and women are being recruited for the ACT I study. Patients may qualify if they:

  • Are at least 18 but less than 80 years of age
  • Have been diagnosed with severe carotid artery disease and require treatment
  • Have not had symptoms related to carotid artery disease in the past 6 months
  • Are not at high risk for surgery
Are you a candidate?

If you or a loved one have been diagnosed with carotid artery disease, you may want to learn more about the ACT I study. Your doctor may be participating as an investigator in the ACT I study. If so, ask him or her for more details and requirements for participation. You may also receive additional information by searching for the keyword ACT I at www.clinicaltrials.gov.

People who participate in clinical trials benefit in many ways, whether they receive the experimental procedure or the one to which it’s compared. All of these patients:

  • Obtain medical care at leading healthcare facilities participating in the study
  • Play a more active role in their own treatment and care
  • Help others by contributing to the understanding of their disease

 

Reference
  1. American Heart Association. Heart Disease and Stroke Statistics—2006 Update. Dallas, Tex: American Heart Association; 2006.


Carotid stenting is not currently approved by the FDA for asymptomatic patients who are at standard risk for surgery.
CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.