Using a percutaneous left ventricular assist device to support high-risk PCI in complex coronary patients

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

This trial tests whether the VADLINK percutaneous left ventricular assist device works better and is as safe as VA‑ECMO for people with very weak hearts who need high‑risk PCI.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 286 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Suzhou Hengruihongyuan Medical Technology Co. LTD (Industry-sponsored)
• Locations: 15 sites (Beijing, Beijing Municipality and 14 other locations)
• Trial ID: NCT07053618 on ClinicalTrials.gov

What this trial studies

This interventional study compares the VADLINK percutaneous left ventricular assist device with venoarterial extracorporeal membrane oxygenation (VA‑ECMO) for circulatory support during complex, high‑risk percutaneous coronary intervention (PCI). Eligible patients are adults with severe left ventricular dysfunction (LVEF ≤35%) for whom coronary bypass is high‑risk or refused and who have high‑risk coronary anatomy on angiography. Participants will receive either VADLINK implantation or VA‑ECMO during PCI and will be followed for safety and efficacy outcomes. The trial is being conducted at multiple tertiary hospitals in China.

Who should consider this trial

Good fit: Ideal candidates are adults 18–90 with LVEF ≤35% who require complex or high‑risk PCI (for example unprotected left main disease, last‑remaining vessel, multivessel disease with CTO, severe calcification) and for whom CABG is high‑risk or refused.

Not a fit: Patients with LVEF >35%, those suitable for standard CABG, or those with contraindications to percutaneous circulatory support or anticoagulation are unlikely to benefit.

Why it matters

Potential benefit: If successful, VADLINK could offer a safer or more effective way to provide circulatory support during very high‑risk PCI, potentially lowering complication rates and improving recovery.

How similar studies have performed: There are observational and device‑experience data for percutaneous LVADs and ECMO, but no prior randomized comparison in CHIP patients, so randomized evidence is limited.

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:

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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Where this trial is running

Beijing, Beijing Municipality and 14 other locations

• Beijing Tsinghua Changgung Hospital — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Zhongshan Hospital Affiliated to Xiamen University — Xiamen, Fujian, China (Not_yet_recruiting)
• The First Hospital of Lanzhou University — Lanzhou, Gansu, China (Not_yet_recruiting)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Nanfang Hospital Southern Medical University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Not_yet_recruiting)
• People's Hospital of Hunan Province — Changsha, Hunan, China (Not_yet_recruiting)
• Suzhou Municipal Hospital — Suzhou, Jiangsu, China (Not_yet_recruiting)
• Jiangxi Provincial People's Hospital — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)
• The People's Hospital of Liaoning Province — Shenyang, Liaining, China (Not_yet_recruiting)
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
• Zhejiang Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Ningbo University — Ningbo, Zhejiang, China (Not_yet_recruiting)
• The First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Jun Jiang

Conditions High-Risk Percutaneous Coronary Intervention; Left Ventricular Assist Devices