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

This study has been completed.
Sponsor:
Information provided by:
Cordis Corporation
ClinicalTrials.gov Identifier:
NCT00438919
First received: February 16, 2007
Last updated: December 2, 2009
Last verified: December 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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

Genders Eligible for Study:   Both
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:

  • None.
  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: 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

No publications provided by Cordis Corporation

Additional 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
Study First Received: February 16, 2007
Last Updated: December 2, 2009
Health Authority: Switzerland: competent authorities

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

ClinicalTrials.gov processed this record on October 22, 2014