Randomized MicroPort's Firehawk DES Versus Xience V

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
MicroPort Medical (Shanghai) Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01196819
First received: September 6, 2010
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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 Intervention Phase
Coronary Artery Disease
Procedure: DES implantation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by MicroPort Medical (Shanghai) Co. Ltd.:

Primary Outcome Measures:
  • 9 months in-stent late lumen loss [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
    To observe in-stent late lumen loss after 9 months of stent implantation


Secondary Outcome Measures:
  • 9 months in-stent percent diameter stenosis [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]

    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:
  • Pre-specified OCT Endpoints [ Time Frame: 3 years after index PCI ] [ Designated as safety issue: No ]

    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


Enrollment: 510
Study Start Date: September 2010
Estimated Study Completion Date: September 2016
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196819

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

No publications provided by MicroPort Medical (Shanghai) Co. Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MicroPort Medical (Shanghai) Co. Ltd.
ClinicalTrials.gov Identifier: NCT01196819     History of Changes
Other Study ID Numbers: Target I
Study First Received: September 6, 2010
Last Updated: April 15, 2014
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 24, 2014