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Interventional Left Ventricular Assist System for PCI in CHIP Patients
Sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD
Summary
Mechanical circulatory support (MCS) is a life-sustaining therapy first introduced in the 1950s. After six decades of development, it now serves as a critical bridge therapy for patients with acute cardiac events and end-stage heart failure. Percutaneous mechanical circulatory support (pMCS), a key MCS modality, has advanced rapidly in recent years. In China, pMCS adoption has accelerated significantly, evidenced by year-over-year growth in both specialized centers and clinical cases, alongside continuous technological refinement. Common pMCS devices include: Intra-Aortic Balloon Pump (IABP), Axial flow pump systems (e.g., Impella®), Extracorporeal Membrane Oxygenation (ECMO). However, no randomized study has compared Impella with VA-ECMO in CHIP patients. The aim of the study is to evaluate the effectiveness and safety of interventional left ventricular assist system (VADLINK) compared to the VA-ECMO in providing circulatory support for complicated and high-risk patient with indications for PCI.
Official title: Interventional Left Ventricular Assist System for PCI in CHIP Patients: a Prospective, Multicenter, Noninferiority Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
286
Start Date
2025-08-06
Completion Date
2027-08-01
Last Updated
2025-08-26
Healthy Volunteers
No
Conditions
Interventions
Implantation of the VADLINK Percutaneous Left Ventricular Assist Device
To implant VADLINK percutaneous left ventricular assist device during percutaneous coronary intervention (PCI).
VA-ECMO
Received venous arterial extracorporeal membrane oxygenation (VA-ECMO) during PCI.
Locations (15)
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
People's Hospital of Hunan Province
Changsha, Hunan, China
Suzhou Municipal Hospital
Suzhou, Jiangsu, China
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The People's Hospital of Liaoning Province
Shenyang, Liaining, China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Zhejiang Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China