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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:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00489320
First received: June 20, 2007
Last updated: August 1, 2007
Last verified: August 2007
  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
Time Perspective: Longitudinal
Official Title: An Observational Registry Using Drug Eluting Stents (DES) in Patients in a Real-World Setting (DEScover Registry).

Resource links provided by NLM:


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

Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: June 20, 2007
Last Updated: August 1, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Cordis Corporation:
Coronary disease
Arteries
Atherosclerosis
Arteriosclerosis

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

ClinicalTrials.gov processed this record on November 27, 2014