Interventional Left Ventricular Assist System for PCI in CHIP Patients

NCT07053618 | Recruiting

• 1 other identifier: CVAD2.0
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 30-day Major Adverse Events (MAE) rate

  Occurrence of a major adverse event (MAE) up to 30 days post-implantation. Major adverse event is a composite endpoint, defined as all-cause death, stroke, myocardial infarction, Unplanned percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG), cardiovascular hospitalization, MCS-ARC defined bleeding types 3, 4, or 5, acute kidney injury, serious device-related adverse events, cardiopulmonary resuscitation or ventricular arrhythmias after electrical cardioversion.

  From enrollment to 30 ±7 days after PCI surgery

Secondary Outcomes (10)

• The MACCE rate

  30, 90 days

• Transfusion rate

  30 days

• Mean units transfused

  30 days

• Incidence of hemodynamic instability

  30 days

• 90-day Major Adverse Events (MAE) rate

  90 days

Study Arms (2)

VADLINK

EXPERIMENTAL

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

Device: Implantation of the VADLINK Percutaneous Left Ventricular Assist Device

V-A ECMO

ACTIVE COMPARATOR

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

Device: VA-ECMO

Interventions

Implantation of the VADLINK Percutaneous Left Ventricular Assist Device DEVICE

To implant VADLINK percutaneous left ventricular assist device during percutaneous coronary intervention (PCI).

VADLINK

VA-ECMO DEVICE

Received venous arterial extracorporeal membrane oxygenation (VA-ECMO) during PCI.

V-A ECMO

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Hengruihongyuan Medical Technology Co. LTD: lead

Study Sites (15)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102218, China

NOT YET RECRUITING

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, 361004, China

NOT YET RECRUITING

The First Hospital of Lanzhou University

Lanzhou, Gansu, 730000, China

NOT YET RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

NOT YET RECRUITING

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, 510515, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

NOT YET RECRUITING

People's Hospital of Hunan Province

Changsha, Hunan, 410005, China

NOT YET RECRUITING

Suzhou Municipal Hospital

Suzhou, Jiangsu, 215002, China

NOT YET RECRUITING

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, 330006, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330006, China

NOT YET RECRUITING

The People's Hospital of Liaoning Province

Shenyang, Liaining, 110015, China

NOT YET RECRUITING

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

Zhejiang Hospital

Hangzhou, Zhejiang, 310013, China

NOT YET RECRUITING

The First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, 315000, China

NOT YET RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

NOT YET RECRUITING

Central Study Contacts

Jun Jiang

CONTACT

+86 135 8870 6891; dyjayj@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: July 8, 2025
• Study Start: August 6, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)