Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis
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.
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
Conditions
Interventions
Device · Other
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
- Sep 30, 2008
- Primary completion
- Mar 31, 2013
- Completion
- Mar 31, 2013
- Last update posted
- May 29, 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 29, 2018 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00576693 live on ClinicalTrials.gov.