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Clinical Trials/NCT00489320
NCT00489320
Completed
Not Applicable

An Observational Registry Using Drug Eluting Stents (DES) in Patients in a Real-World Setting (DEScover Registry).

Cordis Corporation1 site in 1 country7,759 target enrollmentDecember 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiovascular Diseases
Sponsor
Cordis Corporation
Enrollment
7759
Locations
1
Status
Completed
Last Updated
18 years ago

Overview

Brief Summary

The DEScover Registry is designed to observe the results of using Drug Eluting Stents (DES) in patients in a real-world setting. The stents being observed are not investigational, that is, they have been approved for use in the general population.

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.

Registry
clinicaltrials.gov
Start Date
December 2004
End Date
July 2006
Last Updated
18 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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