- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00489320
An Observational Registry Using Drug Eluting Stents (DES) in Patients in a Real-World Setting (DEScover Registry). (DESCOVER)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The D.E.S.cover Registry is a prospective, multi-center, observational study. Consecutive patients undergoing PCI procedures will be asked to consent to participate in this study. For these patients, baseline, clinical and angiographic characteristics, as well as certain procedural and clinical events will be recorded using standardized case report forms. Outcomes will be assessed during hospitalization and at one, six and twelve months after discharge. Depending on results from the first year of follow-up, the study may be extended with an additional one or two years of follow-up.
The strategy for achieving the scientific objectives of the Registry is to document actual, real-world PCI practice and outcomes. Accordingly, the D.E.S.cover Registry does not specify treatment protocols, require any particular assignment of patients to treatment protocols, or in any other way require participating physicians to alter their practice patterns. Participating physicians are instructed to continue to treat all patients according to their own best clinical judgment, but to submit information on the parameters and outcomes of this treatment to the D.E.S.cover Registry database.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Consecutive patients undergoing percutaneous coronary intervention at an enrolling center by study investigators
Exclusion Criteria:
- Patient refusal or inability to provide written informed consent and/or HIPAA authorization
Study Plan
How is the study designed?
Design Details
- Observational Models: Defined Population
- Time Perspectives: Prospective
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David O Williams, Rhode Island Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DESCOVER
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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