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

NACompletedINTERVENTIONAL
Enrollment

222

Participants

Timeline

Start Date

September 10, 2024

Primary Completion Date

May 27, 2025

Study Completion Date

August 13, 2025

Conditions
High Risk PCICoronary 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.

Trial Locations (1)

200032

Zhongshan Hospital Affiliated to Fudan University, Shanghai

All Listed Sponsors
lead

ForQaly Medical (Shanghai) Co., Ltd

INDUSTRY

NCT06853470 - Prospective Evaluation for Receiving SynFlow 3.0 Interventional Circulatory Support in High-risk PCI: A Randomized Controlled Trial | Biotech Hunter | Biotech Hunter