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OpenTrials
Completed

NCT Number: NCT02316886

Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque

The primary aim of the trial is to determine whether preventive PCI with bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) plus optimal medical therapy (OMT) on functionally insignificant (FFR > 0.80) vulnerable coronary plaque, as determined by intracoronary imaging, would result in a significant reduction of the primary composite outcome of death from cardiac causes, target-vessel myocardial infarction (MI), target-vessel revascularization (TVR), and hospitalization for unstable or progressive angina at 2 years, when compared with OMT alone.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Kyoto University Hospital, Kyoto, Japan

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About this study

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)

Extended follow-up:

Considering the nature of functionally insignificant coronary stenosis with vulnerable plaque, most subjects are watched for extended follow-up after the planned 2-year follow-up time point.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged ≥18 years
  • Patients with suspected or known Coronary artery disease who are undergoing invasive cardiac catheterization
  • Patients with at least one significant stenosis (diameter stenosis >50%) with Fractional Flow Reserve (FFR) >0.80 and meeting two of the following criteria:
  • MLA(minimal luminal area)<4mm2
  • Plaque burden>70%
  • Large lipid-rich plaque on NIRS(Intracoronary Near-Infrared Spectroscopy), defined as MaxLCBI4mm>315
  • TCFA(thin-cap fibroatheroma) defined as fibrous cap thickness <65 μm and arc >90° on optical coherence tomography (OCT) or ≥10% confluent necrotic core with >30° abutting the lumen in three consecutive slices on Virtual-histology intravascular ultrasound (VH-IVUS)
  • Eligible for percutaneous coronary intervention with Absorb Bioresorbable Vascular Scaffold or Everolimus Eluting Stent
  • Reference vessel diameter 2.75-4.0
  • Lesion length ≤ 40mm
  • Willing and able to provide informed written consent

Exclusion criteria

  • Patients for whom the preferred treatment is CABG(Coronary artery bypass grafting)
  • Patients with stented lesions
  • Patients with bypass graft lesions
  • Patients with three or more target lesions
  • Patients with two target lesions in the same coronary territory
  • Patients with heavily calcified or angulated lesions
  • Patients with bifurcation lesions requiring 2 stenting technique
  • Patients with contraindications to or planned discontinuation of dual antiplatelet therapy within 1 year
  • Patients with life expectancy <2 years
  • Patients with planned cardiac or major noncardiac surgery
  • Woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study

Treatment and study plan

coronary intervention

Device

bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) + Optimal Medical Treatment

Optimal medical treatment

Drug

Primary outcomes

  1. Target vessel failure

    Time frame: 2 years

    target-vessel failure, which was defined a composite of death from cardiac causes, target-vessel myocardial infarction, ischemic-driven target-vessel revascularization, or hospitalization for unstable or progressive angina

Secondary outcomes

  1. Death from cardiac causes

    Time frame: 2 years

  2. Target-vessel myocardial infarction

    Time frame: 2 years

  3. Ischemic-driven target-vessel revascularization

    Time frame: 2 years

  4. Hospitalization for unstable or progressive angina

    Time frame: 2 years

  5. Death from all, cardiac, or noncardiac causes

    Time frame: 2 years

  6. Myocardial infarction

    Time frame: 2 years

    Periprocedural or spontaneous, target-vessel or non-target-vessel related

  7. Repeat revascularization

    Time frame: 2 years

    Repeat revascularization (target-vessel or non-target-vessel, ischemia-driven or non-ischemia-driven)

  8. Any hospitalization for cardiac or noncardiac causes

    Time frame: 2 years

  9. Target-lesion failure

    Time frame: 2 years

    cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization

  10. Major adverse cardiac event

    Time frame: 2 years

    defined as death from cardiovascular causes, nonfatal myocardial infarction, or unplanned rehospitalization due to unstable or progressive angina

  11. Composite of any death, myocardial infarction, or repeat revascularization

    Time frame: 2 years

    A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event is considered to have occurred if any one of several different events is observed.

  12. Rate of Scaffold or stent thrombosis

    Time frame: 2 years

  13. Rate of Stroke

    Time frame: 2 years

  14. Rate of Bleeding events

    Time frame: 2 years

    life-threatening or disabling, major or minor

  15. Rate of Nonurgent revascularization procedures

    Time frame: 2 years

  16. Functional class

    Time frame: 2 years

    It is assessed by the Canadian Cardiovascular Society (CCS) Classification at each point in time.

    The Canadian Cardiovascular Society (CCS) classification has four categories; the minimum and maximum values are 1 and 4 respectively. A higher score means a worse outcome.

  17. Number of anti-anginal medications administered

    Time frame: 2 years

    Number of anti-anginal medication at each point in time

Sponsors and collaborators

Lead sponsor

Seung-Jung Park

Other

Collaborators

  • CardioVascular Research Foundation, Korea

Registry information

Official study title

a Multinational, Multicenter, Prospective, Open-label, Active-treatment-controlled Randomized Trial: Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque_PREVENT Trial

Acronym: PREVENT

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Dec 15, 2014
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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