RecruitingNot ApplicableNCT07053618

Interventional Left Ventricular Assist System for PCI in CHIP Patients

Interventional Left Ventricular Assist System for PCI in CHIP Patients: a Prospective, Multicenter, Noninferiority Randomized Controlled Trial


Sponsor

Suzhou Hengruihongyuan Medical Technology Co. LTD

Enrollment

286 participants

Start Date

Aug 6, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Implantation of the VADLINK Percutaneous Left Ventricular Assist Device and a medical device called VA-ECMO for people with high-risk percutaneous coronary intervention (high-risk pci) and left ventricular assist devices. The study is currently recruiting participants at 15 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEImplantation of the VADLINK Percutaneous Left Ventricular Assist Device

To implant VADLINK percutaneous left ventricular assist device during percutaneous coronary intervention (PCI).

DEVICEVA-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

View Full Details on ClinicalTrials.gov

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NCT07053618


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