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

Primary Purpose

Coronary Artery Stenosis

Status
Withdrawn
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Firebird 2 SES
Cypher SES
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Stenosis focused on measuring significant stenosis (>70% of lumen stenosis), epicardial coronary arteries.

Eligibility Criteria

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

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

Sites / Locations

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Firebird 2 stent group

Cypher Stent Group

Arm Description

patients who were implated with Firebird 2 SES

patients who were implanted with Cypher SES

Outcomes

Primary Outcome Measures

in-stent late lumen loss at 9 months' angiographic follow-up
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

Secondary Outcome Measures

target vessel failure
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]).

Full Information

First Posted
April 1, 2011
Last Updated
June 13, 2011
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01328730
Brief Title
The Real-world Firebird 2 Versus Cypher Sirolimus-eluting Stent in Treating Patients With Coronary Artery Disease
Acronym
REFIRE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Withdrawn
Why Stopped
the Cypher SES is now withdrawing in China market
Study Start Date
April 2011 (undefined)
Primary Completion Date
March 2012 (Anticipated)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Stenosis
Keywords
significant stenosis (>70% of lumen stenosis), epicardial coronary arteries.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
430 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Firebird 2 stent group
Arm Type
Experimental
Arm Description
patients who were implated with Firebird 2 SES
Arm Title
Cypher Stent Group
Arm Type
Active Comparator
Arm Description
patients who were implanted with Cypher SES
Intervention Type
Device
Intervention Name(s)
Firebird 2 SES
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Cypher SES
Intervention Description
The Cypher SES is based on the 316L platform with Controlled-release, nonresorbable, elastomeric polymer coating.
Primary Outcome Measure Information:
Title
in-stent late lumen loss at 9 months' angiographic follow-up
Description
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
Time Frame
9 months
Secondary Outcome Measure Information:
Title
target vessel failure
Description
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]).
Time Frame
1, and 2 years after index procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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