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COMPLETED
NCT06853470
NA

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

Sponsor: ForQaly Medical (Shanghai) Co., Ltd

View on ClinicalTrials.gov

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.

Official title: Safety and Efficacy of the SynFlow 3.0 Percutaneous Transvalvular Ventricular Assist System in Patients Undergoing High-Risk PCI: A Prospective, Multicenter, Randomized Controlled, Non-inferiority Trial (PERSIST Ⅲ Study)

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

222

Start Date

2024-09-10

Completion Date

2025-08-13

Last Updated

2026-08-05

Healthy Volunteers

No

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.

Locations (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China