Prospective Evaluation for Receiving SynFlow 3.0 Interventional Circulatory Support in High-risk PCI: A Randomized Controlled Trial

Summary

This study is conducted to compare the effectiveness of a new percutaneous mechanical circulatory support device called SynFlow 3.0 with VA-ECMO in high-risk percutaneous coronary intervetnion(PCI) patients. The objective of this study is to see if SynFlow 3.0 can provide similar or better support during high-risk PCI compared to VA-ECMO.

Specifically, the following questions is to be answered in this study:

Can SynFlow 3.0 provide sufficient hemodynamic support for patients during high-risk PCI and the effect be similar to VA-ECMO? Does SynFlow 3.0 offer other clinical benefits compared to VA-ECMO? By answering these questions, it will be determined if SynFlow 3.0 can be a viable alternative to VA-ECMO for patients undergoing high-risk PCI.

Conditions

• High Risk PCI
• Coronary Arterial Disease (CAD)

Interventions

DEVICE

VA-ECMO circulatory support

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a percutaneous mechanical circulatory support device that can provide short-term hemodynamic support during high-risk PCI.

DEVICE

SynFlow 3.0 circulatory support

The SynFlow 3.0 is a novel percutaneous left ventricular-assist device that can provide temporary hemodynamic support during high-risk procedure.

PROCEDURE

percutaneous coronary intervention

The percutaneous coronary intervention is a percutaneous endovascular intervention technique that can restore coronary blood flow by various intervention methods such as angioplasty and stent implantation.

Sponsors & Collaborators

• ForQaly Medical (Shanghai) Co., Ltd

  lead INDUSTRY

Principal Investigators

• Jianan Wang, Phd · Second Affiliated Hospital, School of Medicine, Zhejiang University

• Dan Song, Phd · Wuhan Asia Heart Hospital

• Bo Luan, Phd · Liaoning Provincial People's Hospital

• Chuanyu Gao, Phd · Fuwai Huazhong Cardiovascular Hospital

• Cheng Zhang, Phd · Qilu Hospital of Shandong University

• Jingping Wang, Phd · Shanxi Cardiovascular Hospital

• Zuyi Yuan, Phd · First Affiliated Hospital Xi'an Jiaotong University

• Yining Yang, Phd · People's Hospital of Xinjiang Uygur Autonomous Region

• Yan Wang · Xiamen Cardiovascular Hospital

• Yan Li, Phd · The Second Affiliated Hospital of Air Force Medical University

• Yansong Guo, Phd · Fujian Provincial Hospital

• Ming Bai, Phd · LanZhou University

• Renqiang Yang, Phd · Second Affiliated Hospital of Nanchang University

• Jiancheng Xiu, Phd · Nanfang Hospital, Southern Medical University

• Jianhong Tao, Phd · Sichuan Academy of Medical Sciences

• Min Dai, Phd · Mianyang Central Hospital

• Lin Zhao, Phd · Beijing Chao Yang Hospital

• Yundai Chen, Phd · First Medical Center of the General Hospital of the People's Liberation Army

• Junbo Ge, Phd · Shanghai Zhongshan Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-10

Primary Completion

2025-05-27

Completion

2025-08-13

Countries

• China

Study Locations