Drug Eluting Stent Registry of Thrombosis (DESERT)
This study has been completed.
Sponsor:
Medstar Research Institute
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
| Tracking Information | |
|---|---|
| First Received Date ICMJE | December 18, 2008 |
| Last Updated Date | April 22, 2013 |
| Start Date ICMJE | September 2009 |
| Primary Completion Date | May 2012 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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 ] |
| Original Primary Outcome Measures ICMJE | Same as current |
| Change History | Complete list of historical versions of study NCT00812552 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Drug Eluting Stent Registry of Thrombosis |
| Official Title ICMJE | Drug Eluting Stent Registry of Thrombosis |
| 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. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Retrospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| 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). |
| Condition ICMJE | Coronary Artery Disease |
| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) |
|
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 984 |
| Completion Date | May 2012 |
| Primary Completion Date | May 2012 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States, Canada, Switzerland |
| Administrative Information | |
| NCT Number ICMJE | NCT00812552 |
| Other Study ID Numbers ICMJE | DESERT |
| Has Data Monitoring Committee | Not Provided |
| Responsible Party | Medstar Research Institute |
| Study Sponsor ICMJE | Medstar Research Institute |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Medstar Research Institute |
| Verification Date | April 2013 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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