Clinical trial NCT00812552: Drug Eluting Stent Registry of Thrombosis
Official title: Drug Eluting Stent Registry of Thrombosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Medstar Health Research Institute
Sponsor class: OTHER
First posted: 2008-12-22
Enrollment: 984
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, male or female, over 18 years of age, who are either known to have experienced late or very late drug-eluting stent thrombosis (Case), or have undergone drug-eluting stent implantation at the same facility, in the same time period as a matched Case Subject, and have not experienced drug-eluting stent thrombosis (Control).

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: To assess for potential correlates surrounding subjects and lesions among patients that experience late or very late drug-eluting stent thrombosis
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Mercy General Hospital / Mercy Heart and Vascular Institute Cardiovascular Research
state: California
city: Washington
country: United States
facility: Washington Hospital Center
state: District of Columbia
city: Springfield
country: United States
facility: Prairie Education and Research Cooperative
state: Illinois
city: Lexington
country: United States
facility: Lexington Cardiac Research Foundation/Central Baptist Hospital
state: Kentucky
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Takoma Park
country: United States
facility: Washington Adventist Hospital
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Kansas City
country: United States
facility: Saint Luke's Hospital, Mid America Heart Institute
state: Missouri
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Baptist Medical Center
state: North Carolina
city: Akron
country: United States
facility: Summa Health System
state: Ohio
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Columbia
country: United States
facility: South Carolina Heart Center, PA
state: South Carolina
city: Winchester
country: United States
facility: Winchester Medical Center
state: Virginia
city: Quebec City
country: Canada
facility: Laval Hospital
state: Quebec
city: Bern
country: Switzerland
facility: Bern University Hospital
Study officials:
References:
citation: Waksman R, Kirtane AJ, Torguson R, Cohen DJ, Ryan T, Raber L, Applegate R, Waxman S, Gordon P, Kaneshige K, Leon MB; DESERT Investigators. Correlates and outcomes of late and very late drug-eluting stent thrombosis: results from DESERT (International Drug-Eluting Stent Event Registry of Thrombosis). JACC Cardiovasc Interv. 2014 Oct;7(10):1093-102. doi: 10.1016/j.jcin.2014.04.017. Epub 2014 Sep 17.