NCT06853470

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 222 (actual)
• Sponsor: ForQaly Medical (Shanghai) Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The study is a prospective, multicenter, randomized controlled trial under the Good Clinical Principles(GCP) carried out in more than 15 research centers over China. Patients with 3-vessel disease, unprotected left main coronary artery disease or last patent conduit and severly depressed left ventricular function (LVEF≤35%) will be enrolled and undergo non-emergent PCI, and be randomized 1:1 to receive either the SynFlow 3.0 or VA-ECMO support during the PCI. The primary endpoint is the incidence of 30-day major adverse events.

Conditions

• High Risk PCI
• Coronary Arterial Disease (CAD)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-10
• Primary completion: 2025-05-27
• Completion: 2025-08-13
• First posted: 2025-03-03
• Last updated: 2025-08-29

Locations

1 site across 1 country: China