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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
286
To implant VADLINK percutaneous left ventricular assist device during percutaneous coronary intervention (PCI).
Received venous arterial extracorporeal membrane oxygenation (VA-ECMO) during PCI.
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGZhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, China
NOT_YET_RECRUITINGThe First Hospital of Lanzhou University
Lanzhou, Gansu, China
NOT_YET_RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGNanfang Hospital Southern Medical University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
NOT_YET_RECRUITINGPeople's Hospital of Hunan Province
Changsha, Hunan, China
NOT_YET_RECRUITINGSuzhou Municipal Hospital
Suzhou, Jiangsu, China
NOT_YET_RECRUITINGJiangxi Provincial People's Hospital
Nanchang, Jiangxi, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
NOT_YET_RECRUITING...and 5 more locations
30-day Major Adverse Events (MAE) rate
Occurrence of a major adverse event (MAE) up to 30 days post-implantation. Major adverse event is a composite endpoint, defined as all-cause death, stroke, myocardial infarction, Unplanned percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), cardiovascular hospitalization, MCS-ARC defined bleeding types 3, 4, or 5, acute kidney injury, serious device-related adverse events, cardiopulmonary resuscitation or ventricular arrhythmias after electrical cardioversion.
Time frame: From enrollment to 30 ±7 days after PCI surgery
The MACCE rate
Incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) within 30 or 90 days after surgery.
Time frame: 30, 90 days
Transfusion rate
Transfusion rate within 30 days after surgery.
Time frame: 30 days
Mean units transfused
Mean Number of Blood Units Transfused within 30 Days Postoperatively.
Time frame: 30 days
Incidence of hemodynamic instability
Incidence of hemodynamic instability within 30 days device implantation.
Time frame: 30 days
90-day Major Adverse Events (MAE) rate
Time frame: 90 days
Incidence of device-related adverse events
Time frame: Implant up through 90 days
Incidence of device-related serious adverse events
Time frame: Implant up through 90 days
Incidence of adverse events
Time frame: Implant up through 90 days
Serious adverse event incidence rate
Time frame: Implant up through 90 days
Incidence of device defects
Time frame: Periprocedural
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