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.
Unprotected left main (LM) coronary artery disease (coronary stenosis ≥ 50%).
A last remaining patent coronary artery (the anterior descending artery (LAD) and/or its branches, the circumflex artery (LCX) and/or its branches, and the right coronary artery (RCA) and/or its branches).
Saphenous vein graft (SVG) vascular lesions.
Severely calcification, tortuosity.
Cardiogenic shock (CS) within 7 days (Cardiogenic shock: Sustained SBP <90 mmHg for ≥30 min or requiring supportive measures to maintain SBP >90 mmHg and end-organ hypoperfusion (urine output <30 ml/h or cool extremities).
STEMI or CK-MB did not return to the normal range within 24 hours.
Cardiac arrest with cardiopulmonary resuscitation within 24 hours.
Left ventricular mural thrombus.
Suzhou Hengruihongyuan Medical Technology Co. LTD
Lead sponsor