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Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease (FESTA)

This study is currently recruiting participants.
Verified June 2011 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01373632
First received: June 13, 2011
Last updated: June 14, 2011
Last verified: June 2011
History of Changes
  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 Excel SES (JW Medical, Shandong, China, MA) with biodegradable polymer has been proved by several 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) with durable polymer, comparing with Excel SES.


Condition Intervention Phase
Coronary Artery Disease
 Device: Firebird 2 sirolimus-eluting stent
Device: Excel sirolimus-eluting stent
 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: Multicenter, Randomized, Non-inferiority Study of Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease

Resource links provided by NLM:

U.S. FDA Resources

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 ]
    patients are planned to receive angiographic follow-up at 9 months after index procedure, and in-stent late lumen loss will be analyzed


Secondary Outcome Measures:
  • target vessel failure [ Time Frame: 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: 570
Study Start Date: June 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Firebird 2 stent group
the patients who receive Firebird 2 stent
 Device: Firebird 2 sirolimus-eluting stent
the Firebird 2 sirolimus-eluting stent is a SES with durable polymer based on Co-Cr stent platform
Active Comparator: Excel stent group
the patients who receive Excel stent
 Device: Excel sirolimus-eluting stent
the Excel sirolimus-eluting stent is a stent with biodegradable polymer (PLA) based on stainless steel (316L) stent platform

  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-pregnant 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373632

Locations
China, Shanghai
Ruijin Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200025
Contact: WeiFeng Shen, MD, PhD     86-21-64370045 ext 665215     rjshenweifeng@yahoo.com.cn    
Contact: Xian Zhang, MD     86-21-64370045 ext 665215        
Principal Investigator: WeiFeng Shen, MD, PhD            
Sub-Investigator: Qi Zhang, MD, PhD            
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
  More Information

Publications:

Responsible Party: Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Cardiovascular Department
ClinicalTrials.gov Identifier: NCT01373632     History of Changes
Other Study ID Numbers: 20110611
Study First Received: June 13, 2011
Last Updated: June 14, 2011
Health Authority: China: Food and Drug Administration

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chlorhexidine
Chlorhexidine gluconate
Sirolimus
Everolimus
Anti-Infective Agents, Local
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 16, 2013