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Coronary Artery DiseaseDESERTNCT00812552

Drug Eluting Stent Registry of Thrombosis

An observational study of Coronary Artery Disease, run by Medstar Health Research Institute at 20 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
How many people
984 participants
Where
20 sitesin 3 countries
Study dates
Sep 2009to May 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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.

Who cannot join

  • Patients not meeting the above Inclusion Criteria

Trial locations and contacts

20 sites in 3 countries.

20 sites in 3 countries

United States18 sites
  • Summa Health System

    Akron, Ohio, 44309

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • New York Methodist Hospital

    Brooklyn, New York, 11215

  • Lahey Clinic

    Burlington, Massachusetts, 01805

  • South Carolina Heart Center, PA

    Columbia, South Carolina, 29204

  • Geisinger Health System

    Danville, Pennsylvania, 17822

  • Saint Luke's Hospital, Mid America Heart Institute

    Kansas City, Missouri, 64111

  • Lexington Cardiac Research Foundation/Central Baptist Hospital

    Lexington, Kentucky, 40503

  • Columbia University Medical Center

    New York, New York, 10032

  • Maine Medical Center

    Portland, Maine, 04102

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • The Valley Hospital

    Ridgewood, New Jersey, 07450

  • Mercy General Hospital / Mercy Heart and Vascular Institute Cardiovascular Research

    Sacramento, California, 95819

  • Prairie Education and Research Cooperative

    Springfield, Illinois, 62701

  • Washington Adventist Hospital

    Takoma Park, Maryland, 20912

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Winchester Medical Center

    Winchester, Virginia, 22601

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

Canada1 site
  • Laval Hospital

    Québec, Quebec, G1V4G5

Other trials in Canada

Switzerland1 site
  • Bern University Hospital

    Bern, 3010

Other trials in Switzerland

About this study

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.

Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00812552
Study groupRoleWhat they receive
CaseLate or very late drug-eluting stent thrombosis
ControlNo drug-eluting stent thrombosis

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Dec 2008 (estimated)
  2. Study startSep 2009
  3. Primary completionMay 2012
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
984 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00812552
Sponsor's protocol ID
DESERT
Acronym
DESERT
Status last verified
Apr 2013
First submitted
18 Dec 2008
Last updated
23 Apr 2013
Results posted
No

Publications

  • 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.

    PubMed 25240540

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Medstar Health Research Institute at 20 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States, Canada, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To assess for potential correlates surrounding subjects and lesions among patients that experience late or very late drug-eluting stent thrombosis (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00812552, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2013.

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