An Observational Registry Using Drug Eluting Stents (DES) in Patients in a Real-World Setting (DEScover Registry). (DESCOVER)
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|ClinicalTrials.gov Identifier: NCT00489320|
Recruitment Status : Completed
First Posted : June 21, 2007
Last Update Posted : August 2, 2007
|Condition or disease||Intervention/treatment|
|Cardiovascular Diseases Vascular Disease Arterial Occlusive Disease Arteriosclerosis Atherosclerosis||Device: Cypher Stent|
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 :||Observational|
|Actual Enrollment :||7759 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||An Observational Registry Using Drug Eluting Stents (DES) in Patients in a Real-World Setting (DEScover Registry).|
|Study Start Date :||December 2004|
|Actual Study Completion Date :||July 2006|
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
|United States, Rhode Island|
|Rhode Island Hospital|
|Providence, Rhode Island, United States, 02903|
|Principal Investigator:||David O Williams||Rhode Island Hospital|