Fractional FLow Reserve And IVUS for Clinical OUtcomes in Patients With InteRmediate Stenosis

Summary

To compare the safety and efficacy of FFR (fractional flow reserve)-guided percutaneous coronary intervention (PCI) strategy with IVUS (intravascular ultrasound \[IVUS\])-guided PCI in patients with intermediate coronary stenosis.

Conditions

• Stable Angina

Interventions

PROCEDURE

FFR-guided stenting

The percutaneous coronaryintervention using drug-eluting stent will be indicated according to following criteria in the FFR-guided strategy arm \* Criteria for revascularization: The FFR ≤ 0.80 will be targeted for PCI

PROCEDURE

IVUS-guided stenting

The percutaneous coronaryintervention using drug-eluting stent will be indicated according to following criteria in the IVUS-guided strategy arm \* Criteria for revascularization: Minimum lumen area (MLA) ≤ 3mm2 or (MLA ≤ 4mm2 AND Plaque burden \>70%)

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  collaborator OTHER

• Samsung Medical Center, Sungkyunkwan University School of Medicine

  collaborator UNKNOWN

• Ulsan University Hospital

  collaborator OTHER

• Keimyung University Dongsan Medical Center

  collaborator OTHER

• Inje University

  collaborator OTHER

• KangWon National University Hospital

  collaborator OTHER

• Ajou University School of Medicine

  collaborator OTHER

• Seoul National University Hospital

  lead OTHER

Principal Investigators

• Bon-Kwon Koo, MD, PhD · Seoul National University Hospital

• Seung-Jea Tahk, MD, PhD · Ajou University School of Medicine

• JianAn Wang, MD, PhD · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-06-30

Primary Completion

2025-02-28

Completion

2025-12-31

Countries

• China
• South Korea

Study Locations