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Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent

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ClinicalTrials.gov Identifier: NCT02014818
Recruitment Status : Unknown
Verified October 2017 by Toshiro Shinke, MD, PhD, Kobe University.
Recruitment status was:  Active, not recruiting
First Posted : December 18, 2013
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Toshiro Shinke, MD, PhD, Kobe University

Tracking Information
First Submitted Date  ICMJE December 12, 2013
First Posted Date  ICMJE December 18, 2013
Last Update Posted Date October 18, 2017
Actual Study Start Date  ICMJE January 2014
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2013)
Rate of stent-strut coverage determined by OCT. [ Time Frame: 3 months ]
Rate of stent-strut coverage determined by OCT at 3 months after stent placement (To observe temporal course from the early stage, the rate of stent-strut coverage in the 1-month arm will also be evaluated in a complementary manner, separately from the 3-month arm.) To identify the factors defining the strut coverage at 1-month or 3-months, from OCT index, blood markers, platelet aggregation test immediately after stenting, the strut coverage of 1 to 3 months
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02014818 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2017)
  • All-cause Death, Cardiac death, MI, Stroke, Major bleeding [ Time Frame: 1-year ]
    All-cause Death, Cardiac death, MI, Stroke, Major bleeding
  • Any TLR [ Time Frame: 1-year ]
    Any target lesion revascularization at 1-year
  • Clinically-driven TLR [ Time Frame: 1 year ]
    Clinically relevant revascularization, such as ischemia driven intervention
  • Any TVR [ Time Frame: 1 year ]
    Any target vessel revascularization including both target lesion and remote lesion.
  • CABG [ Time Frame: 1 year ]
    Coronary artery bypass grafting
  • Any revascularization [ Time Frame: 1 year ]
    Any revascularization including percutaneous intervention and surgical bypass grafting
  • Angiographic binary restenosis [ Time Frame: 12 month ]
    Angiographic restenosis defined as percentage of diameter stenosis more than 50% at target lesion
  • Patient-oriented composite [ Time Frame: 1 year ]
    All-cause death, Any MI including non-target territory, Any repeat revascularization ,Stroke
  • The percentage of stent strut coverage by OCT [ Time Frame: 12 month ]
    Determination of factors associated with 12-month rate of stent-strut coverage on the basis of OCT findings, circulating biomarkers, and platelet aggregation test results immediately after stent placement
  • OCT endpoint [ Time Frame: 1-month or 3-month ]
    • The percentage of stent strut malapposition
    • The presence of Intra-stent thrombus
    • Intra-stent thrombus area (Maximum site)
    • Intra-stent thrombus length
    • The number of Intra-stent thrombus
  • Angiographic Quantitative analysis [ Time Frame: 12 month ]
    • In-segment late loss
    • Minimal lumen diameter (MLD), reference vessel diameter (RVD), percent diameter stenosis (%DS)
    • In-stent late loss
    • Binary restenosis (In-stent, In-segment, Peri-stent)
    • Angiographically detected stent fracture(based on Popma's classification )
  • Angiographic Qualitative analysis [ Time Frame: 12 month ]
    • Peri-stent contrast stain (PSS)
    • Site and pattern of restenosis (based on Mehran clasification)
Original Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2013)
  • All-cause Death, Cardiac death, MI, Stroke, Major bleeding [ Time Frame: 1-year ]
    All-cause Death, Cardiac death, MI, Stroke, Major bleeding
  • Any TLR [ Time Frame: 1-year ]
  • Clinically-driven TLR [ Time Frame: 1 year ]
  • Any TVR [ Time Frame: 1 year ]
  • CABG [ Time Frame: 1 year ]
  • Any revascularization [ Time Frame: 1 year ]
  • Angiographic binary restenosis [ Time Frame: 12 month ]
  • Patient-oriented composite [ Time Frame: 1 year ]
    All-cause death, Any MI including non-target territory, Any repeat revascularization ,Stroke
  • The percentage of stent strut coverage by OCT [ Time Frame: 12 month ]
    Determination of factors associated with 12-month rate of stent-strut coverage on the basis of OCT findings, circulating biomarkers, and platelet aggregation test results immediately after stent placement
  • OCT endpoint [ Time Frame: 1-month or 3-month ]
    • The percentage of stent strut malapposition
    • The presence of Intra-stent thrombus
    • Intra-stent thrombus area (Maximum site)
    • Intra-stent thrombus length
    • The number of Intra-stent thrombus
  • Angiographic Quantitative analysis [ Time Frame: 12 month ]
    • In-segment late loss
    • Minimal lumen diameter (MLD), reference vessel diameter (RVD), percent diameter stenosis (%DS)
    • In-stent late loss
    • Binary restenosis (In-stent, In-segment, Peri-stent)
    • Angiographically detected stent fracture(based on Popma's classification )
  • Angiographic Qualitative analysis [ Time Frame: 12 month ]
    • Peri-stent contrast stain (PSS)
    • Site and pattern of restenosis (based on Mehran clasification)
Current Other Pre-specified Outcome Measures
 (submitted: December 12, 2013)
Platelet Aggregation Test [ Time Frame: At the time of OCT follow-up (1 month or 3 month) and 12 month ]
(1) at the time of PCI, (2) at the time of OCT at 1 or 3 months after PCI, (3) at 12-month follow-up, and (4) at the time of occurrence of a cardio-cerebrovascular event.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent
Official Title  ICMJE Multicenter Comparison of Early and Late Vascular Responses to Everolimus-eluting Cobalt-CHromium Stent and Platelet AggregatioN Studies In Patients With Stable Angina Managed as Elective Case : MECHANISM-Elective
Brief Summary To treat patients with stable coronary artery disease, elective percutaneous coronary intervention (PCI) will be performed with the use of an everolimus-eluting cobalt- chromium stent (everolimus-eluting stent: EES, Xience Prime, Xpedition), which is the current standard drug-eluting stent (DES). Vascular responses at the site of stent placement will be evaluated by optical coherence tomography (OCT) at 1 or 3 months and at 12 months after stent placement, along with observation of changes over time in the target vessel. The relationships between OCT findings and the time course of platelet aggregation and between OCT findings and the occurrence of major cardio- cerebrovascular events will also be elucidated.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This study will comprise of 1 month follow-up and 3-month follow up arm, which enroll patients in a parallel manner.
Masking: Single (Outcomes Assessor)
Masking Description:
All patients' information will be blinded to OCT image analyzers.
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Device: CoCr-EES
Other Names:
  • XIENCE PRIME
  • XIENCE Xpedition
Study Arms  ICMJE
  • Experimental: 3 month OCT follow-up, CoCr-EES
    Elective PCI can be performed with the use of an EES. PCI in another vessel or follow-up angiography is expected to be performed 3 months after the index procedure.
    Intervention: Device: CoCr-EES
  • Experimental: 1 month OCT follow-up, CoCr-EES
    Elective PCI can be performed with the use of an EES. PCI in another vessel or follow-up angiography is expected to be performed 1 months after the index procedure.
    Intervention: Device: CoCr-EES
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 29, 2017)
104
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2013)
100
Estimated Study Completion Date  ICMJE December 31, 2018
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients having at least one de novo lesion in a coronary artery in whom PCI with a DES is indicated
  • Patients aged 20 to less than 85 years at the time of informed consent
  • Patients who have provided informed consent written by themselves
  • Patients who are able to undergo OCT examinations of the site of stent placement at 1 or 3 months and at 12 months

Exclusion Criteria:

  • If it is judged difficult to perform clinical and angiographic follow-up at 12 months (considering the patient's remote place of residence, etc.)
  • Patients with acute myocardial infarction (AMI)
  • Patients in a state of shock
  • Patients with cardiac failure
  • Patients having a culprit lesion in the left main coronary artery trunk
  • Patients having a lesion with a reference vessel diameter of less than 2.0 mm or 4.5 mm or larger by visual estimate
  • Patients having an in-stent restenosis lesion as the culprit lesion
  • Patients having chronic renal failure with a serum creatinine level of 2.0 mg/dL or higher at a screening visit
  • Patients on hemodialysis
  • Cancer patients with a life expectancy of less than 2 years
  • Patients who are scheduled to undergo elective surgery requiring discontinuation of antiplatelet therapy within the next 3 months
  • Pregnant women or women expected to become pregnant
  • Patients with a history of adverse reactions to aspirin or clopidogrel (however, it is acceptable to enroll patients in whom the safety of ticlopidine has been confirmed, even if they have a history of adverse reactions to clopidogrel)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 84 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02014818
Other Study ID Numbers  ICMJE MECHANISM-Elective
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Toshiro Shinke, MD, PhD, Kobe University
Study Sponsor  ICMJE Kobe University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Toshiro Shinke, MD, PhD Kobe University Graduate School of Medicine
PRS Account Kobe University
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP