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Preventive PCI or Medical Therapy Alone for Vulnerable Atherosclerotic Coronary Plaque

NCT02316886 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1608

Last updated 2023-11-18

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Coronary intervention

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

DRUG

Optimal Medical treatment

Sponsors & Collaborators

  • CardioVascular Research Foundation, Korea

    collaborator OTHER

  • Seung-Jung Park

    lead OTHER

Principal Investigators

  • Duk-woo Park, MD · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-05
Primary Completion
2023-10-19
Completion
2023-10-19

Countries

  • United States
  • Japan
  • New Zealand
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02316886 on ClinicalTrials.gov