Coronary Artery Disease Clinical Trial
— DESERTOfficial title:
Drug Eluting Stent Registry of Thrombosis
| Verified date | April 2013 |
| Source | Medstar Research Institute |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Observational |
Multicenter, case-control study, to collect data regarding incidences of late and very late drug-eluting stent thrombosis with the aim of identifying trends and possible correlates of stent thrombosis.
| Status | Completed |
| Enrollment | 984 |
| Est. completion date | May 2012 |
| Est. primary completion date | May 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients over 18 years of age - Case Subjects: patients who have experienced definite late or very late drug-eluting stent thrombosis - Control Subjects: patients who underwent drug-eluting stent implantation at the same facility and in the same time period as a matched Case Subject, and have not experienced drug-eluting stent thrombosis. Exclusion Criteria: - Patients not meeting the above Inclusion Criteria |
Observational Model: Case Control, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Canada | Laval Hospital | Quebec City | Quebec |
| Switzerland | Bern University Hospital | Bern | |
| United States | Summa Health System | Akron | Ohio |
| United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
| United States | New York Methodist Hospital | Brooklyn | New York |
| United States | Lahey Clinic | Burlington | Massachusetts |
| United States | South Carolina Heart Center, PA | Columbia | South Carolina |
| United States | Geisinger Health System | Danville | Pennsylvania |
| United States | Saint Luke's Hospital, Mid America Heart Institute | Kansas City | Missouri |
| United States | Lexington Cardiac Research Foundation/Central Baptist Hospital | Lexington | Kentucky |
| United States | Columbia University Medical Center | New York | New York |
| United States | Maine Medical Center | Portland | Maine |
| United States | The Miriam Hospital | Providence | Rhode Island |
| United States | The Valley Hospital | Ridgewood | New Jersey |
| United States | Mercy General Hospital / Mercy Heart and Vascular Institute Cardiovascular Research | Sacramento | California |
| United States | Prairie Education and Research Cooperative | Springfield | Illinois |
| United States | Washington Adventist Hospital | Takoma Park | Maryland |
| United States | Washington Hospital Center | Washington | District of Columbia |
| United States | Winchester Medical Center | Winchester | Virginia |
| United States | Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Medstar Research Institute |
United States, Canada, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | To assess for potential correlates surrounding subjects and lesions among patients that experience late or very late drug-eluting stent thrombosis | Baseline | No |
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