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

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ClinicalTrials.gov Identifier: NCT00245401
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : April 4, 2007
Sponsor:
Information provided by:
Cordis Corporation

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: CYPHERTM Sirolimus-Eluting Coronary Stent Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 2070 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CYPHERTM Stent Post-Marketing Surveillance Registry (US-PMS)
Study Start Date : August 2003
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus
U.S. FDA Resources




Primary Outcome Measures :
  1. MACE at 30 days, 6 months and 1 year.

Secondary Outcome Measures :
  1. There is no pre-specified secondary outcome.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cypher stent

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00245401


Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Emerson Perin, MD Texas Heart Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00245401     History of Changes
Other Study ID Numbers: P03-6321
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: April 4, 2007
Last Verified: April 2007

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs