Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Drug Eluting Stent Registry of Thrombosis (DESERT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medstar Research Institute
ClinicalTrials.gov Identifier:
NCT00812552
First received: December 18, 2008
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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.


Condition
Coronary Artery Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Drug Eluting Stent Registry of Thrombosis

Further study details as provided by Medstar Research Institute:

Primary Outcome Measures:
  • To assess for potential correlates surrounding subjects and lesions among patients that experience late or very late drug-eluting stent thrombosis [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Enrollment: 984
Study Start Date: September 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Case
Late or very late drug-eluting stent thrombosis
Control
No drug-eluting stent thrombosis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812552

  Show 20 Study Locations
Sponsors and Collaborators
Medstar Research Institute
  More Information

No publications provided

Responsible Party: Medstar Research Institute
ClinicalTrials.gov Identifier: NCT00812552     History of Changes
Other Study ID Numbers: DESERT
Study First Received: December 18, 2008
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Thrombosis
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Embolism and Thrombosis
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014