NCT00245401

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,070

participants targeted

Target at P75+ for phase_4 coronary-artery-disease

Timeline
Completed

Started Aug 2003

Shorter than P25 for phase_4 coronary-artery-disease

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

August 1, 2003

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 28, 2005

Completed
Last Updated

April 4, 2007

Status Verified

April 1, 2007

First QC Date

October 4, 2005

Last Update Submit

April 3, 2007

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • MACE at 30 days, 6 months and 1 year.

Secondary Outcomes (1)

  • There is no pre-specified secondary outcome.

Interventions

CYPHERTM Sirolimus-Eluting Coronary StentDEVICE

Eligibility Criteria

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

You may qualify if:

  • Cypher stent

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bezerra H, Perin E, Berger P, Block P, Ramee S, Katz S, Kellet M, Dippel E, Schaer G, Britto S, Cohen S, Costa M. Outcomes of unselected recipients of sirolimus-eluting stents: the Cypher stent U.S. post-marketing surveillance registry. J Invasive Cardiol. 2010 Feb;22(2):48-55.

    PMID: 20124586DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Emerson Perin, MD

    Texas Heart Institute

    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

October 4, 2005

First Posted

October 28, 2005

Study Start

August 1, 2003

Study Completion

December 1, 2004

Last Updated

April 4, 2007

Record last verified: 2007-04