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SAVE-PCI Ⅱ: NyokAssist™ Small-Bore VAD vs. ECMO in Elective High-Risk PCI
Sponsor: magAssist, Inc.
Summary
SAVE-PCI Ⅱ is a prospective, multi-center, randomized controlled trial evaluating the safety and efficacy of NyokAssist™, a small-bore percutaneous ventricular assist device (pVAD), in comparison with ECMO in patients undergoing elective high-risk percutaneous coronary intervention (PCI).
Official title: A Prospective, Multi-center, Randomized Controlled, Non-Inferiority Trial to Evaluate the Safety and Efficacy of a Percutaneous Ventricular Assist Device
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
204
Start Date
2026-04-09
Completion Date
2027-03-31
Last Updated
2026-10-06
Healthy Volunteers
No
Conditions
Interventions
NyokAssist
The NyokAssist™ Ventricular Assist Device can be placed across the aortic valve using a single femoral site. The device pumps blood from the left ventricle into the ascending aorta .
ECMO
Extracorporeal Membrane Oxygenation provides extracorporeal gas exchange through use of a membrane oxygenator. Blood is drained from a central vein and returned after oxygenation into the arterial circulation .
Locations (14)
Luhe Hospital, Capital Medical University
Beijing, China
The Second Xiangya Hospital of Central South University
Changsha, China
Guangdong Provincial People's Hospital
Guangzhou, China
Nanfang Hospital Southern Medical University
Guangzhou, China
The First Affiliated Hospital of Jinan University
Guangzhou, China
The Second Affiliated Hospital of Nanchang University
Nanchang, China
ZhongShan Hospital Fudan University
Shanghai, China
The First Hospital of China Medical University
Shenyang, China
The Second Affiliated Hospital of Soochow University
Suzhou, China
Tangdu Hospital of Air Force Military Medical University
Xi'an, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, China
Fu Wai Central China Cardiovascular Hospital
Zhengzhou, China
The 7th People's Hospital of Zhengzhou
Zhengzhou, China