French Post-Marketing Surveillance Survey (FR E-REGISTRY)

November 25, 2010 updated by: Cordis Corporation
To assess the safety and effecacy of the Cypher stent ™ & Cypher Select ™ in the normal use of medical practices, within the labeled indications.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Multi-center, retrospective and prospective French register. This register does not impose any constraint on the evaluated population, the procedure, or the required examinations. The local practice routines should be applied.

Study Type

Interventional

Enrollment (Actual)

4080

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with symptomatic ischemic heart disease due to de novo lesions (lesions <30 mm vessel reference diameter of 2.25 mm to 5 mm), assessed visually, native coronary arteries.

Exclusion Criteria:

  • Patients suffering from coronary heart disease.
  • Patients for whom treatment antiplatelet and / or anticoagulant is against the state;
  • Patients with injuries incompatible with the full inflation of a balloon angioplasty;
  • Transplant patients ;
  • Patients with known allergy to Sirolimus, the stainless steel 316L, to polymethacrylates or copolymers polyolefins;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Cypher drug-eluting stent
Device: Cypher stent ™ or Cypher Select ™
Cypher drug-eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
There is no pre-specified endpoint.
Time Frame: 12 Months
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cordis Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

March 3, 2009

First Submitted That Met QC Criteria

March 3, 2009

First Posted (Estimate)

March 4, 2009

Study Record Updates

Last Update Posted (Estimate)

November 29, 2010

Last Update Submitted That Met QC Criteria

November 25, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-FR-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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3
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