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

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Firebird 2 sirolimus-eluting stent
Excel sirolimus-eluting stent
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 Disease focused on measuring significant stenosis (>70% of lumen stenosis), epicardial coronary arteries, clinical ischemic

Eligibility Criteria

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

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

Sites / Locations

  • Ruijin Hospital, Shanghai Jiaotong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Firebird 2 stent group

Excel stent group

Arm Description

the patients who receive Firebird 2 stent

the patients who receive Excel stent

Outcomes

Primary Outcome Measures

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

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
June 13, 2011
Last Updated
June 14, 2011
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01373632
Brief Title
Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease
Acronym
FESTA
Official Title
Multicenter, Randomized, Non-inferiority Study of Firebird 2 Versus Excel Sirolimus-eluting Stent in Treating Real-world Patients With Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
September 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 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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Firebird 2 stent group
Arm Type
Experimental
Arm Description
the patients who receive Firebird 2 stent
Arm Title
Excel stent group
Arm Type
Active Comparator
Arm Description
the patients who receive Excel stent
Intervention Type
Device
Intervention Name(s)
Firebird 2 sirolimus-eluting stent
Intervention Description
the Firebird 2 sirolimus-eluting stent is a SES with durable polymer based on Co-Cr stent platform
Intervention Type
Device
Intervention Name(s)
Excel sirolimus-eluting stent
Intervention Description
the Excel sirolimus-eluting stent is a stent with biodegradable polymer (PLA) based on stainless steel (316L) stent platform
Primary Outcome Measure Information:
Title
in-stent late lumen loss at 9 months' angiographic follow-up
Description
patients are planned to receive angiographic follow-up at 9 months after index procedure, and in-stent late lumen loss will be analyzed
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
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-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
Facility Information:
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
WeiFeng Shen, MD, PhD
Phone
86-21-64370045
Ext
665215
Email
rjshenweifeng@yahoo.com.cn
First Name & Middle Initial & Last Name & Degree
Xian Zhang, MD
Phone
86-21-64370045
Ext
665215
First Name & Middle Initial & Last Name & Degree
WeiFeng Shen, MD, PhD
First Name & Middle Initial & Last Name & Degree
Qi Zhang, MD, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
17442198
Citation
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.
Results Reference
background
PubMed Identifier
18655114
Citation
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.
Results Reference
background

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

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