NCT00812552

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
984

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Typical duration for all trials

Geographic Reach
3 countries

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

April 23, 2013

Status Verified

April 1, 2013

Enrollment Period

2.7 years

First QC Date

December 18, 2008

Last Update Submit

April 22, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • To assess for potential correlates surrounding subjects and lesions among patients that experience late or very late drug-eluting stent thrombosis

    Baseline

Study Arms (2)

Case

Late or very late drug-eluting stent thrombosis

Control

No drug-eluting stent thrombosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Mercy General Hospital / Mercy Heart and Vascular Institute Cardiovascular Research

Sacramento, California, 95819, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Prairie Education and Research Cooperative

Springfield, Illinois, 62701, United States

Location

Lexington Cardiac Research Foundation/Central Baptist Hospital

Lexington, Kentucky, 40503, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Washington Adventist Hospital

Takoma Park, Maryland, 20912, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

Saint Luke's Hospital, Mid America Heart Institute

Kansas City, Missouri, 64111, United States

Location

The Valley Hospital

Ridgewood, New Jersey, 07450, United States

Location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

Summa Health System

Akron, Ohio, 44309, United States

Location

Geisinger Health System

Danville, Pennsylvania, 17822, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

South Carolina Heart Center, PA

Columbia, South Carolina, 29204, United States

Location

Winchester Medical Center

Winchester, Virginia, 22601, United States

Location

Laval Hospital

Québec, Quebec, G1V4G5, Canada

Location

Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2008

First Posted

December 22, 2008

Study Start

September 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

April 23, 2013

Record last verified: 2013-04

Locations