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Completed Phase 3 Interventional Results available

Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis

ClinicalTrials.gov ID: NCT00576693

Public ClinicalTrials.gov record NCT00576693. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 2:09 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

PRIMARY HYPOTHESIS: Compared with intensive medical therapy alone, intracranial angioplasty and stenting combined with intensive medical therapy will decrease the risk of the primary endpoint by 35% over a mean follow-up of two years in high-risk patients patients with 70% - 99% intracranial stenosis who had a transient ischemic attack (TIA) or stroke within 30 days prior to enrollment) with symptomatic stenosis of a major intracranial artery. SUMMARY: The best treatment for prevention of another stroke or TIA in patients with narrowing of one of the arteries in the brain is uncertain. A common treatment is the use of anti-clotting medications to prevent blood clots from forming in the narrowed vessel. There are a variety of medicines used for this purpose. These medications are usually taken for the rest of a patient's life. However, a treatment that has been used successfully together with anti-clotting medications in patients with narrowing of the blood vessels of the heart is now being studied in the blood vessels of the brain. This treatment is called stenting. Recent research has also indicated a benefit in prevention of recurring stroke by Intensive Medical Therapy, which is defined as treating risk factors for stroke like high blood pressure, elevated LDL (low density lipids - the "bad" form of cholesterol) and diabetes. The purpose of this study is to compare the safety and effectiveness of either Intensive Medical Therapy PLUS Stenting or Intensive Medical Therapy ONLY in preventing stroke, heart attacks or death. The study will enroll patients over a 5 year period. Each participant will be involved in the study for a minimum of 1 year and a maximum of 3 years. Fifty different medical centers in the United States are part of this study. Both the Clinical Coordinating Center and the Statistical Coordinating Center for the entire study will be located at Emory University.

Study identification

NCT ID
NCT00576693
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Enrollment
451 participants

Conditions and interventions

Eligibility (public fields only)

Age range
30 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2008 (Type not available)
Primary completion
Apr 2013 (Actual)
Completion
Apr 2013 (Actual)
Last update posted
May 30, 2018

2008 – 2013

United States locations

U.S. sites
50
U.S. states
23
U.S. cities
41
Facility City State ZIP Site status
UAB Medical Center Birmingham Alabama 35294 —
Barrow Neurological Institute - St. Joseph's Hospital and Medical Center Phoenix Arizona 85013 —
Mayo Phoenix Arizona 85054 —
Glendale Adventist Glendale California 91203 —
Cedars Sinai Los Angeles California 90048 —
UCLA Los Angeles California 90095 —
UCSF San Francisco California 94143 —
Washington Hospital Washington D.C. District of Columbia 20010 —
University of Florida - Shands Gainesville Florida 32611 —
University of Miami Miami Florida 33136 —
Florida Hospital Winter Park Florida 32789 —
Emory University Atlanta Georgia 30388 —
Rush University Medical Center Chicago Illinois 60612 —
Central DuPage Hospital Winfield Illinois 60190 —
Johns Hopkins Baltimore Maryland 21287 —
Massachusetts General Hospital Boston Massachusetts 02114 —
Wayne State Detroit Michigan 48201 —
Henry Ford Medical Center Detroit Michigan 48202 —
Providence St. John Southfield Michigan 48075 —
University of Mississippi Jackson Mississippi 39216 —
University of Buffalo Buffalo New York 14209 —
NYU Medical Center New York New York 10016 —
Columbia University Medical Center New York New York 10032 —
Cornell Medical College New York New York 10065 —
Stony Brook University Medical Center Stony Brook New York 11790 —
Carolinas Medical Center Charlotte North Carolina 28204 —
Duke University Medical Center Durham North Carolina 27710 —
Moses Cone Medical Center Greensboro North Carolina 27401 —
Forsyth Medical Center Winston-Salem North Carolina 27103 —
University of Cincinnati Cincinnati Ohio 45219 —
University Hospitals Case Medical Center Cleveland Ohio 44106 —
Cleveland Clinic Cleveland Ohio 44195 —
Riverside Methodist Columbus Ohio 43214 —
Oregon Health Sciences University Portland Oregon 97239 —
University of Pennsylvania Philadelphia Pennsylvania 19104 —
Thomas Jefferson University Philadelphia Pennsylvania 19170 —
University of Pittsburgh Pittsburgh Pennsylvania 15213 —
Medical University of South Carolina Charleston South Carolina 29425 —
Erlanger Medical Center Chattanooga Tennessee 37403 —
Baylor University Medical Center Dallas Texas 75246 —
UT Southwestern Dallas Texas 75390 —
Baylor St. Luke's Houston Texas 77030 —
Methodist Hospital Houston Texas 77030 —
Scott & White - Texas A&M Temple Texas 76508 —
Inova Fairfax Hospital Falls Church Virginia 22042 —
Sentera Norfolk Virginia 23507 —
Sacred Heart Medical Center Spokane Washington 99204 —
MultiCare Tacoma Washington 98405 —
West Virginia University Morgantown West Virginia 26506 —
Medical College of Wisconsin Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00576693, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 30, 2018 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00576693 live on ClinicalTrials.gov.

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