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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02316886
Registration number
NCT02316886
Ethics application status
Date submitted
1/12/2014
Date registered
15/12/2014
Titles & IDs
Public title
Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque
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Scientific 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
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Secondary ID [1]
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AMCCV2014-13
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Universal Trial Number (UTN)
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Trial acronym
PREVENT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Coronary Artery Disease
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Plaque, Atherosclerotic
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Coronary intervention
Experimental: Coronary intervention - bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) +Optimal Medical Treatment
Active comparator: Optimal Medical Treatment - Optimal Medical Treatment
Treatment: Devices: Coronary intervention
bioabsorbable vascular scaffolds (BVS) (early period) or everolimus-eluting stents (middle and late period) + Optimal Medical Treatment
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Target vessel failure
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Assessment method [1]
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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
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Timepoint [1]
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2 years
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Secondary outcome [1]
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Death from cardiac causes
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Assessment method [1]
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0
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Timepoint [1]
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2 years
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Secondary outcome [2]
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Target-vessel myocardial infarction
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Assessment method [2]
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0
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Timepoint [2]
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2 years
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Secondary outcome [3]
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Ischemic-driven target-vessel revascularization
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Assessment method [3]
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0
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Timepoint [3]
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2 years
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Secondary outcome [4]
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Hospitalization for unstable or progressive angina
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Assessment method [4]
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0
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Timepoint [4]
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2 years
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Secondary outcome [5]
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Death from all, cardiac, or noncardiac causes
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Assessment method [5]
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0
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Timepoint [5]
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2 years
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Secondary outcome [6]
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Myocardial infarction
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Assessment method [6]
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Periprocedural or spontaneous, target-vessel or non-target-vessel related
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Timepoint [6]
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2 years
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Secondary outcome [7]
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Repeat revascularization
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Assessment method [7]
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Repeat revascularization (target-vessel or non-target-vessel, ischemia-driven or non-ischemia-driven)
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Timepoint [7]
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2 years
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Secondary outcome [8]
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Any hospitalization for cardiac or noncardiac causes
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Assessment method [8]
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0
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Timepoint [8]
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2 years
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Secondary outcome [9]
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Target-lesion failure
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Assessment method [9]
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cardiac death, target-vessel myocardial infarction or ischemia-driven target-lesion revascularization
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Timepoint [9]
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2 years
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Secondary outcome [10]
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Major adverse cardiac event
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Assessment method [10]
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defined as death from cardiovascular causes, nonfatal myocardial infarction, or unplanned rehospitalization due to unstable or progressive angina
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Timepoint [10]
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2 years
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Secondary outcome [11]
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Composite of any death, myocardial infarction, or repeat revascularization
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Assessment method [11]
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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.
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Timepoint [11]
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2 years
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Secondary outcome [12]
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Rate of Scaffold or stent thrombosis
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Assessment method [12]
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0
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Timepoint [12]
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2 years
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Secondary outcome [13]
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Rate of Stroke
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Assessment method [13]
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0
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Timepoint [13]
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2 years
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Secondary outcome [14]
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Rate of Bleeding events
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Assessment method [14]
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life-threatening or disabling, major or minor
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Timepoint [14]
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2 years
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Secondary outcome [15]
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Rate of Nonurgent revascularization procedures
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Assessment method [15]
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0
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Timepoint [15]
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2 years
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Secondary outcome [16]
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Functional class
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Assessment method [16]
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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.
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Timepoint [16]
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2 years
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Secondary outcome [17]
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Number of anti-anginal medications administered
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Assessment method [17]
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Number of anti-anginal medication at each point in time
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Timepoint [17]
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2 years
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Eligibility
Key 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:
1. MLA(minimal luminal area)<4mm2
2. Plaque burden>70%
3. Large lipid-rich plaque on NIRS(Intracoronary Near-Infrared Spectroscopy), defined as MaxLCBI4mm>315
4. 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/10/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
19/10/2023
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Sample size
Target
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Accrual to date
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Final
1608
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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New York
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Country [2]
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Japan
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State/province [2]
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Kyoto
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Country [3]
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Korea, Republic of
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State/province [3]
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Songpa-gu
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Country [4]
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Korea, Republic of
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State/province [4]
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Anyang
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Country [5]
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Korea, Republic of
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State/province [5]
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Chuncheon
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Country [6]
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Korea, Republic of
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State/province [6]
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Daegu
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Country [7]
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Korea, Republic of
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State/province [7]
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Daejeon
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Country [8]
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Korea, Republic of
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State/province [8]
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Gwangju
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Country [9]
0
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Korea, Republic of
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State/province [9]
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Incheon
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Country [10]
0
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Korea, Republic of
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State/province [10]
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Jeonju
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Country [11]
0
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Korea, Republic of
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State/province [11]
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Seoul
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Country [12]
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Korea, Republic of
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State/province [12]
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Songnam
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Country [13]
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New Zealand
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State/province [13]
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Christchurch
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Country [14]
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Taiwan
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State/province [14]
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Taipei
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Funding & Sponsors
Primary sponsor type
Other
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Name
Seung-Jung Park
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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CardioVascular Research Foundation, Korea
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT02316886
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Duk-woo Park, MD
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Address
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Asan Medical Center
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT02316886