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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2070 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2004-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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CYPHERTM Sirolimus-Eluting Coronary Stent

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Cypher stent

Exclusion Criteria

* N/A

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Emerson Perin, MD

Role: PRINCIPAL_INVESTIGATOR

Texas Heart Institute

References

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Bezerra H, Perin E, Berger P, Block P, Ramee S, Katz S, Kellet M, Dippel E, Schaer G, Britto S, Cohen S, Costa M. Outcomes of unselected recipients of sirolimus-eluting stents: the Cypher stent U.S. post-marketing surveillance registry. J Invasive Cardiol. 2010 Feb;22(2):48-55.

Reference Type DERIVED

PMID: 20124586 (View on PubMed)

Other Identifiers

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P03-6321

Identifier Type: -

Identifier Source: org_study_id