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NCT00245401 Clinical Trial

CYPHERTM Stent Post-Marketing Surveillance Registry (US-PMS)

Coronary Artery Disease Clinical Trial

Official title:
CYPHERTM Stent Post-Marketing Surveillance Registry (US-PMS)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00245401
Other study ID # P03-6321
Secondary ID
Status Completed
Phase Phase 4
First received October 4, 2005
Last updated April 3, 2007
Start date August 2003
Est. completion date December 2004

Study information
Verified date April 2007
Source Cordis Corporation
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this PMS registry, named e-CYPHER Stent Registry, is to collect post marketing surveillance data on the CYPHERTM Sirolimus-eluting Coronary Stent following marketing approval, when used in normal clinical practice within the labeled indications.

Recruitment information / eligibility
Status Completed
Enrollment 2070
Est. completion date December 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Cypher stent

Exclusion Criteria:

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• CYPHERTM Sirolimus-Eluting Coronary Stent

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cordis Corporation

Outcome
Type Measure Description Time frame Safety issue
Primary MACE at 30 days, 6 months and 1 year.
Secondary There is no pre-specified secondary outcome.
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