Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by:
Cordis Corporation Identifier:
First received: February 16, 2007
Last updated: December 2, 2009
Last verified: December 2009
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: Open Label
Primary Purpose: Treatment

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.

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

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
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 identifier: NCT00438919

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Hans-Peter Stoll - Medical Affairs Director, Cordis Identifier: NCT00438919     History of Changes
Other Study ID Numbers: EC06-01
Study First Received: February 16, 2007
Last Updated: December 2, 2009

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases processed this record on May 25, 2017