Interventional Left Ventricular Assist System for PCI in CHIP Patients

Official title

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

Overview

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.

Interventions

• Device Implantation of the VADLINK Percutaneous Left Ventricular Assist Device
  To implant VADLINK percutaneous left ventricular assist device during percutaneous coronary intervention (PCI).
• Device VA-ECMO
  Received venous arterial extracorporeal membrane oxygenation (VA-ECMO) during PCI.

Primary outcome measures

• 30-day Major Adverse Events (MAE) rate [Time frame: From enrollment to 30 ±7 days after PCI surgery]

Secondary outcome measures (10)

• The MACCE rate [Time frame: 30, 90 days]
• Transfusion rate [Time frame: 30 days]
• Mean units transfused [Time frame: 30 days]
• Incidence of hemodynamic instability [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]

Eligibility criteria

Inclusion criteria

1\. 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).

3\. 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.

5\. Patients who are able to give informed consent and complete the follow-up.

Exclusion criteria

• 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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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 15 centers

• Beijing Tsinghua Changgung Hospital — Beijing
• Zhongshan Hospital Affiliated to Xiamen University — Xiamen
• The First Hospital of Lanzhou University — Lanzhou
• Guangdong Provincial People's Hospital — Guangzhou
• Nanfang Hospital Southern Medical University — Guangzhou
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou
• People's Hospital of Hunan Province — Changsha
• Suzhou Municipal Hospital — Suzhou
• … and 7 more centers

Identifiers

NCT: NCT07053618 · CVAD2.0

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗