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

This study has been withdrawn prior to enrollment.
(the Cypher SES is now withdrawing in China market)
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01328730
First received: April 1, 2011
Last updated: June 13, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Coronary Artery Stenosis
Device: Firebird 2 SES
Device: Cypher SES
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • in-stent late lumen loss at 9 months' angiographic follow-up [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 1, and 2 years after index procedure ] [ Designated as safety issue: Yes ]
    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]).


Estimated Enrollment: 430
Study Start Date: April 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328730

Locations
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai, China, 200025
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
  More Information

No publications provided

Responsible Party: Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Cardiovascular Department
ClinicalTrials.gov Identifier: NCT01328730     History of Changes
Other Study ID Numbers: RJH20110331
Study First Received: April 1, 2011
Last Updated: June 13, 2011
Health Authority: Institution of Cardiovascular Disease, Shanghai Jiaotong University School of Medicine: China

Keywords provided by Shanghai Jiao Tong University School of Medicine:
significant stenosis (>70% of lumen stenosis)
epicardial coronary arteries.

Additional relevant MeSH terms:
Constriction, Pathologic
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Pathological Conditions, Anatomical
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on July 23, 2014