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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00489320
First Posted: June 21, 2007
Last Update Posted: August 2, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cordis Corporation
  Purpose
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.

Condition Intervention
Cardiovascular Diseases Vascular Disease Arterial Occlusive Disease Arteriosclerosis Atherosclerosis Device: Cypher Stent

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: An Observational Registry Using Drug Eluting Stents (DES) in Patients in a Real-World Setting (DEScover Registry).

Further study details as provided by Cordis Corporation:

Enrollment: 7759
Study Start Date: December 2004
Study Completion Date: July 2006
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489320


Locations
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: David O Williams Rhode Island Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00489320     History of Changes
Other Study ID Numbers: DESCOVER
First Submitted: June 20, 2007
First Posted: June 21, 2007
Last Update Posted: August 2, 2007
Last Verified: August 2007

Keywords provided by Cordis Corporation:
Coronary disease
Arteries
Atherosclerosis
Arteriosclerosis

Additional relevant MeSH terms:
Cardiovascular Diseases
Atherosclerosis
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases