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)

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

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

Inclusion Criteria:

  • Cypher stent

Exclusion Criteria:

  • N/A
  Contacts and Locations
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
Sirolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 17, 2014