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RECRUITING
NCT07860671
NA

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

Sponsor: magAssist, Inc.

View on ClinicalTrials.gov

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

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

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