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A Multi-center Post-Market Surveillance Registry (E-SELECT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00438919
First Posted: February 22, 2007
Last Update Posted: December 3, 2009
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
This multicenter, prospective, observational registry will evaluate the safety and performance of the CYPHER SELECT™ Sirolimus-eluting Coronary Stent, and of all future generation of commercially approved Cordis Sirolimus-eluting Stents (SES), in routine clinical practice. Its objective is to measure the incidence and identify the predictors of acute, sub-acute and late stent thrombosis and Major Adverse Cardiac Events (MACE). Additional analyses will be performed in patient sub-populations, such as diabetes, in-stent restenosis (ISR), acute myocardial infarction (AMI) and multivessel coronary disease.

Condition Intervention Phase
Coronary Artery Disease Device: drug-eluting 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: The e-SELECT Registry a MULTICENTER POST-MARKET SURVEILLANCE

Further study details as provided by Cordis Corporation:

Primary Outcome Measures:
  • acute, sub-acute and late stent thrombosis; Major Adverse Cardiac Events (MACE) [ Time Frame: 1, 6, 12, 24 and 36 months ]

Estimated Enrollment: 15000
Study Start Date: May 2006
Study Completion Date: December 2009
Arms Assigned Interventions
Experimental: 1
CYPHER SELECT™ Sirolimus-eluting Coronary Stent
Device: drug-eluting stent
CYPHER SELECT™ Sirolimus-eluting Coronary Stent

Detailed Description:
The data will be collected in consecutive subjects treated with commercially available product and following standard clinical practice. This registry will be limited to subjects who have received only the CYPHER SELECT™ Sirolimus-eluting Coronary Stent during the index procedure. While no inclusion or exclusion criteria have been specified, uniform, complete and accurate data will be collected peri-procedurally, during the index hospitalization, and during follow-up. All subjects should be treated according to the Instruction For Use (IFU) including conduct of the stenting procedure, application of antiplatelet medication and any other medical therapy should be provided according to local usual practice. Data collection (Electronic Data Capture), data management, statistical analyses, monitoring and core laboratory evaluations will be assigned to independent organizations.
  Eligibility

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:

  • This registry will be limited to subjects who have received only the CYPHER SELECT™ Sirolimus-eluting Coronary Stent during the index procedure;
  • Males and females;

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): NCT00438919


Locations
Switzerland
Clinique La Tour
Meyrin, Switzerland, 1217
Sponsors and Collaborators
Cordis Corporation
Investigators
Principal Investigator: Philip Urban, MD Clinique La Tour
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Hans-Peter Stoll - Medical Affairs Director, Cordis
ClinicalTrials.gov Identifier: NCT00438919     History of Changes
Other Study ID Numbers: EC06-01
First Submitted: February 16, 2007
First Posted: February 22, 2007
Last Update Posted: December 3, 2009
Last Verified: December 2009

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