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

June 14, 2011 updated by: Shanghai Jiao Tong University School of Medicine

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

570

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
        • Contact:
        • Contact:
          • Xian Zhang, MD
          • Phone Number: 665215 86-21-64370045
        • Principal Investigator:
          • WeiFeng Shen, MD, PhD
        • Sub-Investigator:
          • Qi Zhang, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 9 months
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
Time Frame: 2 years after index procedure
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

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110611

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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