The Real-world Firebird 2 Versus Cypher Sirolimus-eluting Stent in Treating Patients With Coronary Artery Disease (REFIRE)

June 13, 2011 updated by: Shanghai Jiao Tong University School of Medicine

Post-marketing Study Comparing the Efficacy and Safety of Firebird 2 Versus Cypher Sirolimus-eluting Stents in Treating Patients With Coronary Artery Disease in China

Sirolimus-eluting stent (SES) has been world-widely used in clinical practice in treating patients with coronary artery disease (CAD). The efficacy and safety of Cypher SES (Cordis, MA) has been proved by several randomized clinical trials. Here the investigators design a prospective, multicenter, randomized clinical study in purpose of identifying the non-inferiority in the efficacy and safety in treating CAD patients by Firebird 2 SES (Microport, Shanghai), comparing with Cypher SES.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

430

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

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:

  • age > 18 years
  • male or un-preganant female
  • stenosis > 70% in one of major the epicardial coronary arteries
  • no contra-indications of stent implantation
  • singed the informed consent

Exclusion Criteria:

  • acute myocardial infarction within one week
  • have contra-indications of stent implantation or can not tolerate dual antiplatelet therapy
  • no history of stent implantation within last one-year
  • received other brand coronary stent during index procedure
  • with no achievement of informed consent

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Firebird 2 stent group
patients who were implated with Firebird 2 SES
Device: Firebird 2 SES
The FIREBIRD2™ Rapamycin-Eluting CoCr Coronary Stent is the second generation DES of MicroPort, which based on the new cobalt chromium alloy stent platform. It uses polyolefin polymer, which makes the coating property very remarkable.
ACTIVE_COMPARATOR: Cypher Stent Group
patients who were implanted with Cypher SES
Device: Cypher SES
The Cypher SES is based on the 316L platform with Controlled-release, nonresorbable, elastomeric polymer coating.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
in-stent late lumen loss at 9 months' angiographic follow-up
Time Frame: 9 months
Late luminal loss was defined as the difference between the minimal luminal diameter immediately after the placement of the stent and the minimal luminal diameter at 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
target vessel failure
Time Frame: 1, and 2 years after index procedure
defined as the occurrence of any of the following within 1 and 2 years after the index procedure: death from cardiac causes, Q-wave or non-Q-wave myocardial infarction, or revascularizationof the target vessel (emergency or elective coronaryartery bypass grafting [CABG] or repeated percutaneous transluminal coronary angioplasty [PTCA]).
1, and 2 years after index procedure

Collaborators and Investigators

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

Sponsor

Shanghai Jiao Tong University School of Medicine

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

April 1, 2011

Primary Completion (ANTICIPATED)

March 1, 2012

Study Completion (ANTICIPATED)

June 1, 2013

Study Registration Dates

First Submitted

April 1, 2011

First Submitted That Met QC Criteria

April 4, 2011

First Posted (ESTIMATE)

April 5, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 14, 2011

Last Update Submitted That Met QC Criteria

June 13, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RJH20110331

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.

Clinical Trials on Coronary Artery Stenosis

Clinical Trials on Firebird 2 SES

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe