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ACTIVE NOT RECRUITING
NCT07010965
NA

SAVE-PCI: NyokAssist™ Small-Bore VAD vs. IABP in Elective High-Risk PCI

Sponsor: magAssist, Inc.

View on ClinicalTrials.gov

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

DEVICE

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 .

DEVICE

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