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CYPHERTM Stent Post-Marketing Surveillance Registry (US-PMS)

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

CYPHERTM Sirolimus-Eluting Coronary Stent

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Cypher stent Exclusion Criteria: N/A

Sites / Locations

Outcomes

Primary Outcome Measures

MACE at 30 days, 6 months and 1 year.

Secondary Outcome Measures

There is no pre-specified secondary outcome.

Full Information

NCT ID

NCT00245401

First Posted

October 4, 2005

Last Updated

April 3, 2007

Sponsor

Cordis Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00245401

Brief Title

CYPHERTM Stent Post-Marketing Surveillance Registry (US-PMS)

Official Title

CYPHERTM Stent Post-Marketing Surveillance Registry (US-PMS)

Study Type

Interventional

2. Study Status

Record Verification Date

April 2007

Overall Recruitment Status

Completed

Study Start Date

August 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Cordis Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

2070 (false)

8. Arms, Groups, and Interventions

Intervention Type

Device

Intervention Name(s)

CYPHERTM Sirolimus-Eluting Coronary Stent

Primary Outcome Measure Information:

Title

MACE at 30 days, 6 months and 1 year.

Secondary Outcome Measure Information:

Title

There is no pre-specified secondary outcome.

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Cypher stent Exclusion Criteria: N/A

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emerson Perin, MD

Organizational Affiliation

Texas Heart Institute

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

20124586

Citation

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.

Results Reference

derived

Learn more about this trial

CYPHERTM Stent Post-Marketing Surveillance Registry (US-PMS)

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