SAVE-PCI 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 intra-aortic balloon pump (IABP) in patients undergoing elective high-risk percutaneous coronary intervention (PCI).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
236
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 .
IABP uses counterpulsation to provide coronary flow
Beijing Anzhen Hospital Capital Medical University
Beijing, China
The Second Xiangya Hospital of Central South University
Changsha, China
Guangdong Provincial People's Hospital
Guangzhou, China
MACCE-free rate
The Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) Free Rate
Time frame: Device Delivery through 30 Days
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Nanfang Hospital Southern Medical University
Guangzhou, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, China
The First Hospital of Lanzhou University
Lanzhou, China
ZhongShan Hospital Fudan University
Shanghai, China
Peking University First Hospital Taiyuan Hospital
Taiyuan, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
...and 2 more locations