Trials / Completed
CompletedNCT00489320
An Observational Registry Using Drug Eluting Stents (DES) in Patients in a Real-World Setting (DEScover Registry).
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 7,759 (actual)
- Sponsor
- Cordis US Corp. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Cypher Stent |
Timeline
- Start date
- 2004-12-01
- Completion
- 2006-07-01
- First posted
- 2007-06-21
- Last updated
- 2007-08-02
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00489320. Inclusion in this directory is not an endorsement.