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

Multicenter, Randomized, Non-inferiority Study of Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Firebird 2 sirolimus-eluting stent; Device: Excel sirolimus-eluting stent

• Study Type: Interventional
• Enrollment (Anticipated): 570
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
      • Contact: WeiFeng Shen, MD, PhD; Phone Number: 665215 86-21-64370045; Email: rjshenweifeng@yahoo.com.cn
      • Contact: Xian Zhang, MD; Phone Number: 665215 86-21-64370045
      • Principal Investigator: WeiFeng Shen, MD, PhD
      • Sub-Investigator: Qi Zhang, MD, PhD

Participation Criteria

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-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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]).	2 years after index procedure

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Publications and helpful links

General Publications

• Zhang Q, Xu B, Yang YJ, Zhang RY, Li JP, Qiao SB, Zhang JS, Hu J, Qin XW, Hong T, Chen JL, Huo Y, Shen WF, Gao RL. Sirolimus-eluting cobalt alloyed stents in treating patients with coronary artery disease: six-month angiographic and one-year clinical follow-up result. A prospective, historically controlled, multi-center clinical study. Chin Med J (Engl). 2007 Apr 5;120(7):533-8.
• Han Y, Jing Q, Chen X, Wang S, Ma Y, Liu H, Luan B, Wang G, Li Y, Wang Z, Wang D, Xu B, Gao R. Long-term clinical, angiographic, and intravascular ultrasound outcomes of biodegradable polymer-coated sirolimus-eluting stents. Catheter Cardiovasc Interv. 2008 Aug 1;72(2):177-83. doi: 10.1002/ccd.21600.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (ANTICIPATED): June 1, 2012
• Study Completion (ANTICIPATED): September 1, 2013

Study Registration Dates

• First Submitted: June 13, 2011
• First Submitted That Met QC Criteria: June 14, 2011
• First Posted (ESTIMATE): June 15, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 15, 2011
• Last Update Submitted That Met QC Criteria: June 14, 2011
• Last Verified: June 1, 2011

More Information

Terms related to this study

• Keywords: significant stenosis (>70% of lumen stenosis); epicardial coronary arteries; clinical ischemic
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Anti-Bacterial Agents; Antibiotics, Antineoplastic; Antifungal Agents; Sirolimus
• Other Study ID Numbers: 20110611