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Randomized MicroPort's Firehawk DES Versus Xience V

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01196819
Recruitment Status : Unknown
Verified April 2014 by Shanghai MicroPort Medical (Group) Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : September 8, 2010
Last Update Posted : April 16, 2014
Information provided by (Responsible Party):
Shanghai MicroPort Medical (Group) Co., Ltd.

Brief Summary:

The purpose of this randomized study is to evaluate new generation of MicroPort's DES of its safety, efficacy and delivery system in treating CAD.

The end point is to observe in-stent late lumen loss after 9 months of the stent implantation. The second end point is to study in-stent percent diameter stenosis.

This study is based on non-inferior assumption (vs. Xience V DES), requiring both end points reach statistical significance.

Prespecified OCT follow-up is planned at 3-Year after index PCI at 3 chosen hospitals.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: DES implantation Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 510 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Randomized Trial Assessing the Safety and Effectiveness of FIREHAWK BiodeGradable Polymer TArget Release Rapamycin-Eluting STent vs. XIENCE V Everolimus-Eluting Stent for the Treatment of Coronary Artery Disease: TARGET I Trial
Study Start Date : September 2010
Primary Completion Date : September 2012
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Xience V DES as comparative arm
Use Xience V DES as control group
Procedure: DES implantation
Implant DES for CAD cases
Experimental: MicroPort Firehawk DES
Use MicroPort's new generation of Firehawk drug eluting stent
Procedure: DES implantation
Implant DES for CAD cases

Primary Outcome Measures :
  1. 9 months in-stent late lumen loss [ Time Frame: 9 months ]
    To observe in-stent late lumen loss after 9 months of stent implantation

Secondary Outcome Measures :
  1. 9 months in-stent percent diameter stenosis [ Time Frame: 9 months ]

    Device, lesion, & clinical success rates In-stent p-edge, d-edge & in-segment BRR, in-segment LLL, in-stent and in-segment percent diameter stenosis, at 9-month, respectively

    • Device oriented composite of cardiac death, target vessel MI, or ischemia-driven TLR (TLF) at 1-, 6-, 12-month, and annually up to 5 yrs
    • Patient oriented composite of all cause death, all MI, or any revascularization at 1-, 6-, 12-month, and annually up to 5 yrs
    • Definite and probable stent thrombosis according to ARC
    • Proportion of side branch slow flow and occlusion after stent implantation

Other Outcome Measures:
  1. Pre-specified OCT Endpoints [ Time Frame: 3 years after index PCI ]

    Major Endpoint:

    In-stent volumetric obstruction (%) at 3 years

    Secondary Endpoints:

    • Mean / minimal stent diameter / area / volume at 3 years
    • Mean / minimal lumen diameter / area / volume at 3 years
    • Mean / maximal thickness of the strut coverage at 3 years
    • Proportion of covered struts at 3 years
    • Incomplete stent apposition at 3 years
    • Incomplete stent apposition (ISA) >2 mm2
    • Thrombus > 300 microns2
    • Late lumen loss at 3 years
    • Binary restenosis rates at 3 years

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18-75, male or women who are not pregnant
  • Evidence of non-symptomatic ischemia, stable or non-stable angina or past heart attack cases
  • Target lesion is primary, single artery and single lesion of coronary artery
  • Target lesion vessel length ≤24mm, diameter 2.25mm-4.0mm
  • Lesion diameter stenosis ≥70%
  • Candidates understand the study, willing to sign Consent of Agreement and to willing to accept follow-up For long lesion group, at least one target lesion length ≥28mm,diameter 2.5mm-4.0mm, and one lesion needs to implant 33mm 0r 38mm long stent

Exclusion Criteria:

  • Acute heart attack within one week
  • Chronic complete stenosis (TIMI 0), left main lesion, three branches need to treat, branch vessel diameter ≤2.5mm and bypass lesion
  • Calcified lesion failed in pre-dilation and twisted lesion
  • In-stent restenosis
  • Stent implanted within one year
  • Severe heart failure (NYHA above III) or left ventricle EF <40%
  • Renal function damage, blood creatinine >2.0mg/dl
  • Bleeding risk; allergic to drugs and agents used in procedure/treatment
  • Life expectation < 12 months
  • No compliances to the protocol
  • Heart implantation cases

Pre-specified OCT inclusion/exclusion criteria:

  • Patients underwent 9-month angio F/U
  • No binary restenosis at 9-month
  • LLL between -0.01~0.2mm
  • No mix-implanted stent
  • No more than one bail-out stent
  • No TLR occurred at 3 years after PCI
  • The target vessel able to deliver the OCT catheter

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01196819

Fuwai Hospital
Beijing, China, 100037
Sponsors and Collaborators
Shanghai MicroPort Medical (Group) Co., Ltd.
Principal Investigator: Runlin Gao, Pro & MD Fuwai Hospital, Beijing, China

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Shanghai MicroPort Medical (Group) Co., Ltd.
ClinicalTrials.gov Identifier: NCT01196819     History of Changes
Other Study ID Numbers: Target I
First Posted: September 8, 2010    Key Record Dates
Last Update Posted: April 16, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases