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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00812552
Other study ID # DESERT
Secondary ID
Status Completed
Phase N/A
First received December 18, 2008
Last updated April 22, 2013
Start date September 2009
Est. completion date May 2012

Study information

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

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Medstar Research Institute

Countries where clinical trial is conducted

United States,  Canada,  Switzerland, 

Outcome

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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