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SAVE-PCI: NyokAssist™ Small-Bore VAD vs. IABP in Elective High-Risk PCI
Sponsor: magAssist, Inc.
Summary
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).
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
236
Start Date
2024-07-31
Completion Date
2026-01-31
Last Updated
2026-01-12
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 .
IABP Intra-aortic balloon pump
IABP uses counterpulsation to provide coronary flow
Locations (12)
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
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
Xiamen Cardiovascular Hospital Xiamen University
Xiamen, China
Fuwai Yunnan Hospital Chinese Academy of Medical Science
Yunnan, China