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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02316886
Recruitment Status : Recruiting
First Posted : December 15, 2014
Last Update Posted : July 18, 2019
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Plaque, Atherosclerotic Device: Coronary intervention Drug: Optimal Medical treatment Phase 4

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Preventive Coronary Intervention on Stenosis With Functionally Insignificant Stenosis With Vulnerable Plaque Characteristics
Actual Study Start Date : October 5, 2015
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: Coronary intervention
Bioresorbable Vascular Scaffold or Everolimus Eluting stent (EES) +Optimal Medical Treatment
Device: Coronary intervention
Bioresorbable Vascular Scaffold or Everolimus Eluting stent (EES) +Optimal Medical Treatment

Active Comparator: Optimal Medical Treatment
Optimal Medical Treatment
Drug: Optimal Medical treatment



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Major adverse cardiac event [ Time Frame: 2 years ]
    defined as cardiovascular death, nonfatal myocardial infarction, or unplanned rehospitalization due to unstable angina

  2. Target lesion failure, defined as a composite of cardiovascular death, target lesion related myocardial infarction, or target lesion revascularization [ Time Frame: 2 years ]
  3. Death from any causes [ Time Frame: 2 years ]
  4. The composite of death, myocardial infarction, and any repeat revascularization [ Time Frame: 2 years ]
  5. Cardiac death [ Time Frame: 2 years ]
    Cardiac death

  6. Target vessel-related myocardial infarction [ Time Frame: 2 years ]
  7. Target vessel revascularization [ Time Frame: 2 years ]
  8. 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

  9. 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

  10. 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

  11. 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

  12. Non-urgent revascularization procedures [ Time Frame: 2 years ]
  13. Unplanned hospitalization for angina [ Time Frame: 2 years ]
  14. CCS(Canadian Cardiovascular Society) angina class [ Time Frame: 2 years ]
  15. Number of anti-anginal medication [ Time Frame: 1 month ]
    Number of anti-anginal medication at each point in time

  16. Number of anti-anginal medication [ Time Frame: 6 months ]
    Number of anti-anginal medication at each point in time

  17. Number of anti-anginal medication [ Time Frame: 12 months ]
    Number of anti-anginal medication at each point in time

  18. Number of anti-anginal medication [ Time Frame: 2 years ]
    Number of anti-anginal medication at each point in time

  19. Rate of non-urgent (repeat) revascularization [ Time Frame: 1 month ]
    Rate of non-urgent (repeat) revascularization at each point in time

  20. Rate of non-urgent (repeat) revascularization [ Time Frame: 6 months ]
    Rate of non-urgent (repeat) revascularization at each point in time

  21. Rate of non-urgent (repeat) revascularization [ Time Frame: 12 months ]
    Rate of non-urgent (repeat) revascularization at each point in time

  22. Rate of non-urgent (repeat) revascularization [ Time Frame: 2-year ]
    Rate of non-urgent (repeat) revascularization at each point in time



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02316886


Contacts
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Contact: Jung-Min Ahn, MD drjmahn@gmail.com
Contact: Jung-Hee Ham, RN cvcrc5@amc.seoul.kr

Locations
Show Show 35 study locations
Sponsors and Collaborators
Seung-Jung Park
CardioVascular Research Foundation, Korea
Investigators
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Principal Investigator: Gregg Stone, MD Columbia University
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Responsible Party: Seung-Jung Park, MD,PhD, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02316886    
Other Study ID Numbers: AMCCV2014-13
First Posted: December 15, 2014    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Seung-Jung Park, Asan Medical Center:
coronary intervention
Vulnerable Plaque
Insignificant Stenosis
Bioresorbable Vascular Scaffold
Everolimus Eluting stent
Additional relevant MeSH terms:
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Coronary Artery Disease
Constriction, Pathologic
Plaque, Atherosclerotic
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathological Conditions, Anatomical