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The Preventive Coronary Intervention on Stenosis With Functionally Insignificant Vulnerable Plaque (PREVENT)

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: NCT02316886
Recruitment Status : Active, not recruiting
First Posted : December 15, 2014
Last Update Posted : November 2, 2021
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE December 1, 2014
First Posted Date  ICMJE December 15, 2014
Last Update Posted Date November 2, 2021
Actual Study Start Date  ICMJE October 5, 2015
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
Target vessel failure [ Time Frame: 2 years ]
Target vessel failure (TVF) is defined as a composite of cardiac death, target vessel related MI, ischemia-driven target vessel revascularization, or unplanned hospitalization for angina.
Original Primary Outcome Measures  ICMJE
 (submitted: December 11, 2014)
  • cardiovascular death [ Time Frame: 24 month ]
  • Nonfatal myocardial infarction [ Time Frame: 24 month ]
  • Unplanned hospitalization leading to unstable angina [ Time Frame: 24 month ]
    Unplanned hospitalization leading to unstable angina as adjudicated by the Clinical Event Committee (CEC).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • Major adverse cardiac event [ Time Frame: 2 years ]
    defined as cardiovascular death, nonfatal myocardial infarction, or unplanned rehospitalization due to unstable angina
  • Target lesion failure, defined as a composite of cardiovascular death, target lesion related myocardial infarction, or target lesion revascularization [ Time Frame: 2 years ]
  • Death from any causes [ Time Frame: 2 years ]
  • The composite of death, myocardial infarction, and any repeat revascularization [ Time Frame: 2 years ]
  • Cardiac death [ Time Frame: 2 years ]
    Cardiac death
  • Target vessel-related myocardial infarction [ Time Frame: 2 years ]
  • Target vessel revascularization [ Time Frame: 2 years ]
  • Cardiac death and combinations of cardiac death with other components of MACE [ Time Frame: 1 month ]
    Cardiac death and combinations of cardiac death with other components of MACE at each time point
  • Cardiac death and combinations of cardiac death with other components of MACE [ Time Frame: 6 months ]
    Cardiac death and combinations of cardiac death with other components of MACE at each time point
  • Cardiac death and combinations of cardiac death with other components of MACE [ Time Frame: 12 months ]
    Cardiac death and combinations of cardiac death with other components of MACE at each time point
  • Cardiac death and combinations of cardiac death with other components of MACE [ Time Frame: 2 years ]
    Cardiac death and combinations of cardiac death with other components of MACE at each time point
  • Non-urgent revascularization procedures [ Time Frame: 2 years ]
  • Unplanned hospitalization for angina [ Time Frame: 2 years ]
  • CCS(Canadian Cardiovascular Society) angina class [ Time Frame: 2 years ]
  • Number of anti-anginal medication [ Time Frame: 1 month ]
    Number of anti-anginal medication at each point in time
  • Number of anti-anginal medication [ Time Frame: 6 months ]
    Number of anti-anginal medication at each point in time
  • Number of anti-anginal medication [ Time Frame: 12 months ]
    Number of anti-anginal medication at each point in time
  • Number of anti-anginal medication [ Time Frame: 2 years ]
    Number of anti-anginal medication at each point in time
  • Rate of non-urgent (repeat) revascularization [ Time Frame: 1 month ]
    Rate of non-urgent (repeat) revascularization at each point in time
  • Rate of non-urgent (repeat) revascularization [ Time Frame: 6 months ]
    Rate of non-urgent (repeat) revascularization at each point in time
  • Rate of non-urgent (repeat) revascularization [ Time Frame: 12 months ]
    Rate of non-urgent (repeat) revascularization at each point in time
  • Rate of non-urgent (repeat) revascularization [ Time Frame: 2-year ]
    Rate of non-urgent (repeat) revascularization at each point in time
Original Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2014)
  • Death from any causes [ Time Frame: 24 month ]
  • The composite of death, MI(myocardial infarction), and any TVR(target vessel revascularization) [ Time Frame: 24 month ]
    The composite of death, MI, and any TVR at a mean of 2 years follow-up.
  • Clinical or ischemic MACCE (The composite of death, MI, stroke and clinical-or ischemic-driven TVR) [ Time Frame: 24 month ]
    Clinical or ischemic MACCE (The composite of death, MI, stroke and clinical-or ischemic-driven TVR) at a mean of 2 years follow-up.
  • Cardiac death and combinations of cardiac death with other components of MACE at each time point [ Time Frame: 1 month ]
    Cardiac death and combinations of cardiac death with other components of MACE at each time point
  • Cardiac death and combinations of cardiac death with other components of MACE at each time point [ Time Frame: 6 month ]
    Cardiac death and combinations of cardiac death with other components of MACE at each time point
  • Cardiac death and combinations of cardiac death with other components of MACE at each time point [ Time Frame: 12 month ]
    Cardiac death and combinations of cardiac death with other components of MACE at each time point
  • Cardiac death and combinations of cardiac death with other components of MACE at each time point [ Time Frame: 24 month ]
    Cardiac death and combinations of cardiac death with other components of MACE at each time point
  • Non-urgent revascularization procedures [ Time Frame: 24 month ]
  • CCS(Canadian Cardiovascular Society) angina class [ Time Frame: 1 month ]
  • CCS(Canadian Cardiovascular Society) angina class [ Time Frame: 6 month ]
  • CCS(Canadian Cardiovascular Society) angina class [ Time Frame: 12 month ]
  • CCS(Canadian Cardiovascular Society) angina class [ Time Frame: 24 month ]
  • Number of anti-anginal medication at each point in time [ Time Frame: 1 month ]
  • Number of anti-anginal medication at each point in time [ Time Frame: 6 month ]
  • Number of anti-anginal medication at each point in time [ Time Frame: 12 month ]
  • Number of anti-anginal medication at each point in time [ Time Frame: 24 month ]
  • Rate of non-urgent (repeat) revascularization at each point in time [ Time Frame: 1 month ]
  • Rate of non-urgent (repeat) revascularization at each point in time [ Time Frame: 6 month ]
  • Rate of non-urgent (repeat) revascularization at each point in time [ Time Frame: 12 month ]
  • Rate of non-urgent (repeat) revascularization at each point in time [ Time Frame: 24 month ]
  • Rate of any cerebrovascular event at each point in time [ Time Frame: 1 month ]
    Rate of any cerebrovascular event at each point in time as adjudicated by the Critical Event Committee (CEC).
  • Rate of any cerebrovascular event at each point in time [ Time Frame: 6 month ]
    Rate of any cerebrovascular event at each point in time as adjudicated by the Critical Event Committee (CEC).
  • Rate of any cerebrovascular event at each point in time [ Time Frame: 12 month ]
    Rate of any cerebrovascular event at each point in time as adjudicated by the Critical Event Committee (CEC).
  • Rate of any cerebrovascular event at each point in time [ Time Frame: 24 month ]
    Rate of any cerebrovascular event at each point in time as adjudicated by the Critical Event Committee (CEC).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Preventive Coronary Intervention on Stenosis With Functionally Insignificant Vulnerable Plaque
Official Title  ICMJE The Preventive Coronary Intervention on Stenosis With Functionally Insignificant Stenosis With Vulnerable Plaque Characteristics
Brief Summary The purpose of this study is to determine whether preventive coronary intervention on functionally insignificant coronary stenosis with vulnerable plaque characteristics plus optimal medical therapy reduces the incidence of the composite of cardiovascular death, target vessel myocardial infarction, or ischemia driven target lesion revascularization compared with optimal medical therapy alone.
Detailed Description

Sub-analysis for each imaging test will be performed as below ;

  • NIRS(Near-infrared spectroscopy)
  • OCT(Optical coherence tomography)
  • VH-IVUS(IVUS-derived virtual histology)
  • IVUS(Intravascular ultrasonography)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • Plaque, Atherosclerotic
Intervention  ICMJE
  • Device: Coronary intervention
    Bioresorbable Vascular Scaffold or Everolimus Eluting stent (EES) +Optimal Medical Treatment
  • Drug: Optimal Medical treatment
Study Arms  ICMJE
  • Experimental: Coronary intervention
    Bioresorbable Vascular Scaffold or Everolimus Eluting stent (EES) +Optimal Medical Treatment
    Intervention: Device: Coronary intervention
  • Active Comparator: Optimal Medical Treatment
    Optimal Medical Treatment
    Intervention: Drug: Optimal Medical treatment
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 1, 2021)
1608
Original Estimated Enrollment  ICMJE
 (submitted: December 11, 2014)
2000
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 years or older
  • Symptomatic or asymptomatic coronary artery disease patients
  • Patients having at least one significant stenosis (diameter stenosis > 50%) with FFR >0.80 and meeting two of the following:

    1. MLA(minimal luminal area)<4mm2
    2. plaque burden>70%
    3. Lipid-rich plaque on NIRS(Intracoronary Near-Infrared Spectroscopy) (defined as maxLCBI4mm>315)
    4. TCFA(thin-cap fibroatheroma) defined by OCT(fibrous cap thickness<65µm and arc>90°) or VH-IVUS≥10% confluent NC with>30° abutting to the lumen in 3 consecutive slices)

      • 2 target vulnerable lesions
  • Eligible for percutaneous coronary intervention with Absorb Bioresorbable Vascular Scaffold or Everolimus Eluting Stent
  • Willing and able to provide informed written consent
  • Reference vessel diameter 2.75-4.0
  • Lesion length ≤ 40

Exclusion Criteria:

  • Patients in whom the preferred treatment is CABG(Coronary artery bypass grafting)
  • Stented lesion
  • Bypass graft lesion
  • The patients who have more than or equal to 3 target lesions
  • 2 target lesions in the same coronary territory
  • Heavily calcified or angulated lesion
  • Bifurcation lesion requiring 2 stenting technique
  • Contraindication to or planned discontinuation of dual antiplatelet therapy within 1 year
  • Life expectancy less than 2 years
  • Planned cardiac surgery or planned major non cardiac surgery
  • Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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,   Korea, Republic of,   New Zealand,   Taiwan,   United States
Removed Location Countries Australia,   China,   Italy,   Singapore
 
Administrative Information
NCT Number  ICMJE NCT02316886
Other Study ID Numbers  ICMJE AMCCV2014-13
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Seung-Jung Park, Asan Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Seung-Jung Park
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE CardioVascular Research Foundation, Korea
Investigators  ICMJE
Principal Investigator: Gregg Stone, MD Columbia University
PRS Account Asan Medical Center
Verification Date November 2021

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