FFR Versus IVUS with Angiography-Derived FFR for Clinical Outcomes in Patients with Coronary Artery Disease

Summary

To compare the clinical outcomes of fractional flow reserve (FFR)-guided strategy versus intravascular ultrasound (IVUS)-guided stent implantation after angiography-derived FFR-based decision-making.

Conditions

• Coronary Artery Disease

Interventions

PROCEDURE

Intravascular ultrasound-guided stent implantation after angiography-derived FFR-based decision-making

The percutaneous coronary intervention will be performed by intravascular ultrasound (IVUS)-guided strategy after angiography-derived FFR-based decision-making: 1. PCI will be performed if angiography-derived FFR ≤0.80 and will be deferred if angiography-derived FFR \>0.80. 2. If PCI is performed, PCI optimization using IVUS will be performed following the recommended criteria: ① Plaque burden at stent edge ≤55%; ② Minimal stent area ≥ 5.5 mm2, or minimal stent area ≥ distal reference lumen area

PROCEDURE

Fractional flow reserve-guided PCI strategy

The percutaneous coronary intervention will be performed by fractional flow reserve (FFR)-guided strategy: 1. PCI will be performed if FFR ≤0.80 and will be deferred if FFR \>0.80. 2. If PCI is performed, PCI optimization using FFR will be performed following the recommended criteria: ① Post-PCI FFR ≥ 0.88, or ② Post-PCI ΔFFR (\[FFR at stent distal edge\] - \[FFR at stent proximal edge\]) \< 0.05

Sponsors & Collaborators

• Seoul National University Hospital

  collaborator OTHER

• Peking University Third Hospital

  collaborator OTHER

• RenJi Hospital

  collaborator OTHER

• Second Affiliated Hospital of Shantou University Medical College

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• The Fourth People's Hospital of Jinan

  collaborator UNKNOWN

• Jinhua Central Hospital

  collaborator OTHER

• The Affiliated Hospital of Hangzhou Normal University

  collaborator OTHER

• Changxing People's Hospital

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• The Affiliated Hospital of Medical College, Ningbo University

  collaborator OTHER

• Keimyung University Dongsan Medical Center

  collaborator OTHER

• Inje University Ilsan Paik Hospital

  collaborator OTHER

• Ulsan University Hospital

  collaborator OTHER

• Uijeongbu Eulji Medical Center

  collaborator UNKNOWN

• Kyungpook National University Hospital

  collaborator OTHER

• Seoul St. Mary's Hospital

  collaborator OTHER

• Yonsei University Wonju Severance Hospital

  collaborator UNKNOWN

• Inje University Haeundae Paik Hospital

  collaborator OTHER

• Sejong General Hospital

  collaborator OTHER

• Chonnam National University Hospital

  collaborator OTHER

• Ningbo Medical Center Lihuili Hospital

  collaborator OTHER_GOV

• The Affiliated Hospital of Shandong University of TCM

  collaborator UNKNOWN

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Principal Investigators

• Jian'an Wang, MD, PhD · Second Affiliated Hospital, School of Medicine, Zhejiang University

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

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-13

Primary Completion

2027-12-01

Completion

2029-12-01

Countries

• China
• South Korea

Study Locations