Interventional Left Ventricular Assist System for PCI in CHIP Patients

Hengruihongyuan Medical Technology

Status: Enrolling

Conditions: Left Ventricular Assist Devices; High-Risk Percutaneous Coronary Intervention (High-risk PCI)

Treatments: Device: VA-ECMO; Device: Implantation of the VADLINK Percutaneous Left Ventricular Assist Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT07053618

CVAD2.0

Details and patient eligibility

About

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.

Enrollment: 286 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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:

1. Unprotected left main (LM) coronary artery disease (coronary stenosis ≥ 50%).
2. 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).
3. Saphenous vein graft (SVG) vascular lesions.
4. Severely calcification, tortuosity.
5. Multivessel disease (two or more) combined with chronic total occlusion (CTO).
6. 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

1. 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).

2. STEMI or CK-MB did not return to the normal range within 24 hours.

3. Cardiac arrest with cardiopulmonary resuscitation within 24 hours.

4. Left ventricular mural thrombus.

5. After aortic valve replacement surgery (mechanical, bioprosthetic).

6. Having used or using ECMO or pVAD (percutaneous ventricular assist device) within 7 days.

7. Moderate to severe aortic stenosis, moderate to severe aortic valve insufficiency.

8. Atrial septal or ventricular septal defects (including post-infarction VSD), or post-myocardial infarction Free-Wall Rupture, or papillary muscle rupture.

9. Severe right heart failure or severe tricuspid valve insufficiency.

10. 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.

11. Severe peripheral arterial stenosis or occlusive lesions.

12. 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).

13. Known contraindications to heparin, contrast agents, or study-required medications (e.g., aspirin, clopidogrel); history of Heparin-induced thrombocytopenia.

14. Active hemorrhage within 1 month.

15. History of stroke or TIA or permanent neurologic deficits within one month prior to the procedure.

16. Renal dysfunction: subject on dialysis or serum creatinine ≥4 mg/dL (353.6 µmol/L) within 7 days.

17. Liver dysfunction: liver AST, ALT and bilirubin >3 times the upper limit of normal within 7 days.

18. Presence or suspected presence of infective endocarditis or systemic infection.

19. Women who are pregnant, breastfeeding, or planning pregnancy during the trial.

20. Participation in another drug or medical device clinical trial.

21. Other conditions deemed by the investigator as unsuitable for participation in this trial.

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Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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286 participants in 2 patient groups

VADLINK

Experimental group

Description:

The VADLINK percutaneous left ventricular assist system will offer intraoperative hemodynamic support during high-risk PCI procedures.

Treatment:

Device: Implantation of the VADLINK Percutaneous Left Ventricular Assist Device

V-A ECMO

Active Comparator group

Description:

The VA-ECMO offers intraoperative hemodynamic support during high-risk PCI procedures.

Treatment:

Device: VA-ECMO