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Randomized MicroPort's Firehawk DES Versus Xience V: TARGET I Trial

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ClinicalTrials.gov Identifier: NCT01196819
Recruitment Status : Completed
First Posted : September 8, 2010
Results First Posted : February 21, 2018
Last Update Posted : February 21, 2018
Sponsor:
Information provided by (Responsible Party):
Shanghai MicroPort Medical (Group) Co., Ltd.

Brief Summary:
The purpose of this study is to evaluate new generation drug eluting stent (DES) of MicroPort of its safety, efficacy and delivery system in treating CAD.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: Firehawk Device: Xience V Not Applicable

Detailed Description:
The primary endpoint is in-stent late lumen loss after 9 months of the stent implantation. The secondary endpoint is in-stent percent diameter stenosis.This study is based on non-inferior assumption (vs. Xience V), requiring both endpoints reach statistical significance. Prespecified OCT follow-up is planned at 3-Year after index procedure at 3 chosen hospitals.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Multi-center Randomized Trial Assessing the Safety and Effectiveness of Biodegradable Polymer Target Release Rapamycin-Eluting STent vs. XIENCE V Everolimus-Eluting Stent for the Treatment of Coronary Artery Disease
Actual Study Start Date : September 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Xience V
Implantation of Xience V drug eluting stent
Device: Xience V
Implantation of Xience V drug eluting stent
Experimental: Firehawk
Implantation of Firehawk drug eluting stent
Device: Firehawk
Implantation of Firehawk drug eluting stent



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 It means the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 9 months after the procedure


Secondary Outcome Measures :
  1. 9 Months In-stent Percent Diameter Stenosis [ Time Frame: 9 months ]
    the in-stent percent diameter stenosis 9 months after the surgery

  2. TLF(Target Lumen Failure) [ Time Frame: 1 years after index PCI ]
    TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death.

  3. TLF(Target Lumen Failure) [ Time Frame: 3 years after index PCI ]
    TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death.

  4. TLF(Target Lumen Failure) [ Time Frame: 5 years after index PCI ]
    TLF include target vessel myocardial infarction, symptom-driven target lesion revascularization and sudden cardiac death.

  5. the Incidence of Stent Thrombsis (ARC Defined) [ Time Frame: 1 years after index PCI ]
  6. the Incidence of Stent Thrombsis (ARC Defined) [ Time Frame: 3 years after index PCI ]
  7. the Incidence of Stent Thrombsis (ARC Defined) [ Time Frame: 5 years after index PCI ]


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

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


Locations
China
Fuwai Hospital
Beijing, China, 100037
Sponsors and Collaborators
Shanghai MicroPort Medical (Group) Co., Ltd.
Investigators
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
Results First Posted: February 21, 2018
Last Update Posted: February 21, 2018
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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