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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00245401
First Posted: October 28, 2005
Last Update Posted: April 4, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Cordis Corporation
  Purpose
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 Intervention Phase
Coronary Artery Disease Device: CYPHERTM Sirolimus-Eluting Coronary Stent Phase 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Cordis Corporation:

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

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

Estimated Enrollment: 2070
Study Start Date: August 2003
Study Completion Date: December 2004
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Cypher stent

Exclusion Criteria:

  Contacts and Locations
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
  More Information

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 Submitted: October 4, 2005
First Posted: October 28, 2005
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