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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
222
Venoarterial extracorporeal membrane oxygenation (VA-ECMO) is a percutaneous mechanical circulatory support device that can provide short-term hemodynamic support during high-risk PCI.
The SynFlow 3.0 is a novel percutaneous left ventricular-assist device that can provide temporary hemodynamic support during high-risk procedure.
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.
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Incidence of Major Adverse Events (MAE)
Time frame: Up to 30 days
Incidence of MAE
Time frame: Up to 90 days
Incidence of major adverse cardiac and cerebral events (MACCE)
Time frame: Up to 30 days, up to 90days
the change of left ventricular ejection fraction (LVEF) compared to baseline
Time frame: before discharge, at 30±7 days, at 90±14 days
the change of New York Heart Association (NYHA) class compared to baseline
Time frame: before discharge, at 30±7 days, at 90±14 days
Total length of hospital stay
Time frame: Up to 30 days
ICU/CCU length of stay
Time frame: Up to 30 days
Incidence of adverse events
Time frame: Up to 90 days
Incidence of serious adverse events
Time frame: Up to 90 days
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