EROSION III: OCT- vs Angio-based Reperfusion Strategy for STEMI

Summary

Brief Summary: This study is a prospective, multicenter, randomized, controlled trial aimed to compare the reperfusion strategy and clinical outcomes of STEMI patients treated by angiography-guided vs. OCT-guided PCI. Patients presenting STEMI with coronary artery diameter stenosis ≤70% and TIMI blood flow grade 3 at index or after thrombus aspiration are randomly assigned to either an OCT-guided group or an angiography-guided group. In OCT-guided group, stent implantation or conservative medical treatment is determined based on OCT findings. Conservative non-stenting strategy will be recommended in those with culprit plaque erosions, certain ruptures without dissection and hematoma, SCAD without obstructive stenosis. In the angiography-guided group, reperfusion strategy is decided by the operators according to the local practice. The rate of stenting during primary PCI and clinical outcomes at 1-month and 1-year are collected.

Conditions

• ST-segment Elevation Myocardial Infarction

Interventions

PROCEDURE

Optical coherence tomography-guided reperfusion strategy

Optical coherence tomography will be used to detect the detailed characteristics of culprit lesion and to decide and optimize the reperfusion strategy according to the established algorithm in the protocol.

Sponsors & Collaborators

• Second Hospital of Jilin University

  collaborator OTHER

• Daqing Oil Field Hospital

  collaborator OTHER

• Tianjin Chest Hospital

  collaborator OTHER

• Second Affiliated Hospital of Nanchang University

  collaborator OTHER

• First Affiliated Hospital of Xinjiang Medical University

  collaborator OTHER

• Beijing Anzhen Hospital

  collaborator OTHER

• First Affiliated Hospital of Guangxi Medical University

  collaborator OTHER

• Peking University First Hospital

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Harbin Medical University

  lead OTHER

Principal Investigators

• Bo Yu · The Second Affiliated Hospital of Harbin Medical University

• Bin Liu · Second Hospital of Jilin University

• Jianping Li · Peking University First Hospital

• Yanqing Wu · Second Affiliated Hospital of Nanchang University

• Ling Li · The First Affiliated Hospital of Zhengzhou University

• Chunmei Wang · Beijing Anzhen Hospital

• Yin Liu · Tianjin Chest Hospital

• Dajun Yuan · The Second Affilated Hospital of Dalian Medical University

• Zhiqi Sun · Daqing Oil Field Hospital

• Yining Yang · First Affiliated Hospital of Xinjiang Medical University

• Xinshun Gu · The Second Hospital of Hebei Medical University

• Lang Li · First Affiliated Hospital of Guangxi Medical University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-12-21

Primary Completion

2020-01-02

Completion

2020-12-24

Countries

• China

Study Locations