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
Suzhou Hengruihongyuan Medical Technology Co. LTD
286 participants
Aug 6, 2025
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
Plain Language Summary
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Interventions
To implant VADLINK percutaneous left ventricular assist device during percutaneous coronary intervention (PCI).
Received venous arterial extracorporeal membrane oxygenation (VA-ECMO) during PCI.
Locations(15)
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NCT07053618