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
Inclusion Criteria9
- \. Aged 18-90 2. The investigator assesses that the subject requires coronary revascularization, but CABG (Coronary Artery Bypass Grafting) is considered high-risk or the subject refuses CABG. The investigator believes the subject may benefit from PCI (Percutaneous Coronary Intervention).
- \. Left ventricular ejection fraction (LVEF) ≤ 35%. 4. Coronary angiography (CAG) or coronary computed tomography angiography (CTA) shows any of the following conditions:
- 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.
- Multivessel disease (two or more) combined with chronic total occlusion (CTO).
- Three-vessel disease. Three-vessel disease is defined as significant stenosis (≥ 70%) in at least one segment of all three major epicardial coronary artery territories: the left anterior descending artery (LAD) and/or its branches, the left circumflex artery (LCX) and/or its branches, and the right coronary artery (RCA) and/or its branches. In a left-dominant coronary system, lesions in the proximal segments of the LAD and LCX are also considered three-vessel disease.
- \. Patients who are able to give informed consent and complete the follow-up.
Exclusion Criteria22
- 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.
- After aortic valve replacement surgery (mechanical, bioprosthetic).
- Having used or using ECMO or pVAD (percutaneous ventricular assist device) within 7 days.
- Moderate to severe aortic stenosis, moderate to severe aortic valve insufficiency.
- Atrial septal or ventricular septal defects (including post-infarction VSD), or post-myocardial infarction Free-Wall Rupture, or papillary muscle rupture.
- Severe right heart failure or severe tricuspid valve insufficiency.
- Disease or abnormality of the aorta that interferes with the procedure, including Marfan syndrome, coarctation of aortic, aortic aneurysm, severe tortuosity or calcification of the aorta.
- Severe peripheral arterial stenosis or occlusive lesions.
- Uncorrectable moderate or severe anemia prior to the procedure (hemoglobin \<90 g/L). Abnormal coagulation function (routine blood test indicates platelet count less than 75×109/L, INR ≥2.0, or fibrinogen ≤1.5 g/L).
- Known contraindications to heparin, contrast agents, or study-required medications (e.g., aspirin, clopidogrel); history of Heparin-induced thrombocytopenia.
- Active hemorrhage within 1 month.
- History of stroke or TIA or permanent neurologic deficits within one month prior to the procedure.
- Renal dysfunction: subject on dialysis or serum creatinine ≥4 mg/dL (353.6 µmol/L) within 7 days.
- Liver dysfunction: liver AST, ALT and bilirubin \>3 times the upper limit of normal within 7 days.
- Presence or suspected presence of infective endocarditis or systemic infection.
- Women who are pregnant, breastfeeding, or planning pregnancy during the trial.
- Participation in another drug or medical device clinical trial.
- Other conditions deemed by the investigator as unsuitable for participation in this trial.
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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)
View Full Details on ClinicalTrials.gov
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NCT07053618