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CompletedNCT00245401Updated Apr 4, 2007

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

A Phase 4 interventional study of CYPHERTM Sirolimus-Eluting Coronary Stent in Coronary Artery Disease, sponsored by Cordis Corporation. Completed. Per ClinicalTrials.gov, last updated 2007-04-04.

Sponsored by Cordis Corporation · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
2,070
Allocation
Non-randomized
Sex
All
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Study 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.

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Conditions studied

  • Coronary Artery Disease
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In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's enrollment of 2,070 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Cordis Corporation is the lead sponsor of 70 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Cypher stent

Exclusion criteria

Exclusion Criteria:

  • N/A
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
2,070 participants

Interventions

  • DeviceCYPHERTM Sirolimus-Eluting Coronary Stent
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What researchers measure

Primary outcomes

  1. MACE at 30 days, 6 months and 1 year.

Secondary outcomes

  1. There is no pre-specified secondary outcome.

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 20124586 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 4, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00245401
Lead sponsor
Cordis Corporation
First posted
Oct 28, 2005
Start date
Aug 2003
Completion
Dec 2004
Last update
Apr 4, 2007

Study contacts

Emerson Perin, MD
principal investigator · Texas Heart Institute

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2007. You cannot join it, but the record below documents what was studied.

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