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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00245401
First received: October 4, 2005
Last updated: April 3, 2007
Last verified: April 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CYPHERTM Stent Post-Marketing Surveillance Registry (US-PMS)

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Cypher stent

Exclusion Criteria:

  • N/A
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00245401

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

No publications provided by Cordis Corporation

Additional 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
Study First Received: October 4, 2005
Last Updated: April 3, 2007
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014