NCT00438919

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15,000

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started May 2006

Typical duration for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 3, 2009

Status Verified

December 1, 2009

First QC Date

February 16, 2007

Last Update Submit

December 2, 2009

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • acute, sub-acute and late stent thrombosis; Major Adverse Cardiac Events (MACE)

    1, 6, 12, 24 and 36 months

Study Arms (1)

1

EXPERIMENTAL

CYPHER SELECT™ Sirolimus-eluting Coronary Stent

Device: drug-eluting stent

Interventions

drug-eluting stentDEVICE

CYPHER SELECT™ Sirolimus-eluting Coronary Stent

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique La Tour

Meyrin, 1217, Switzerland

Location

Related Publications (1)

  • Urban P, Abizaid A, Banning A, Bartorelli AL, Baux AC, Dzavik V, Ellis S, Gao R, Holmes D, Jeong MH, Legrand V, Neumann FJ, Nyakern M, Spaulding C, Worthley S; e-SELECT Investigators. Stent thrombosis and bleeding complications after implantation of sirolimus-eluting coronary stents in an unselected worldwide population: a report from the e-SELECT (Multi-Center Post-Market Surveillance) registry. J Am Coll Cardiol. 2011 Mar 29;57(13):1445-54. doi: 10.1016/j.jacc.2010.11.028.

    PMID: 21435513DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • Philip Urban, MD

    Clinique La Tour

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 16, 2007

First Posted

February 22, 2007

Study Start

May 1, 2006

Study Completion

December 1, 2009

Last Updated

December 3, 2009

Record last verified: 2009-12

Locations

CH(1)