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

NCT ID: NCT00489320

Last Updated: 2007-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7759 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-12-31

Study Completion Date

2006-07-31

Brief Summary

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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

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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.

Conditions

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Cardiovascular Diseases Vascular Disease Arterial Occlusive Disease Arteriosclerosis Atherosclerosis

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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Cypher Stent

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cordis Corporation

INDUSTRY

Sponsor Role lead

Principal Investigators

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David O Williams

Role: PRINCIPAL_INVESTIGATOR

Rhode Island Hospital

Locations

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Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Countries

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United States

References

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Williams DO, Abbott JD, Kip KE; DEScover Investigators. Outcomes of 6906 patients undergoing percutaneous coronary intervention in the era of drug-eluting stents: report of the DEScover Registry. Circulation. 2006 Nov 14;114(20):2154-62. doi: 10.1161/CIRCULATIONAHA.106.667915. Epub 2006 Oct 23.

Reference Type RESULT
PMID: 17060386 (View on PubMed)

Other Identifiers

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DESCOVER

Identifier Type: -

Identifier Source: org_study_id