An Observational Registry Using Drug Eluting Stents (DES) in Patients in a Real-World Setting (DEScover Registry). (DESCOVER)
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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). |
| Enrollment: | 7759 |
| Study Start Date: | December 2004 |
| Study Completion Date: | July 2006 |
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 |
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| United States, Rhode Island | |
| Rhode Island Hospital | |
| Providence, Rhode Island, United States, 02903 | |
| 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 May 22, 2013