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Interventional Left Ventricular Assist System for PCI in CHIP Patients | Clinical Trials | Clareo Health

RECRUITINGNA

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

NCT07053618•Suzhou Hengruihongyuan Medical Technology Co. LTD

View on ClinicalTrials.gov

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

Age

18 - 90 years

Sex

ALL

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.
+12 more criteria

Locations (15)

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Nanfang Hospital Southern Medical University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

People's Hospital of Hunan Province

Changsha, Hunan, China

Suzhou Municipal Hospital

Suzhou, Jiangsu, China

Jiangxi Provincial People's Hospital

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Key Dates

Start Date

August 6, 2025

Primary Completion Date

December 1, 2026

Completion Date

August 1, 2027

Last Updated

August 26, 2025

Enrollment

286

ESTIMATED participants

Conditions

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

Interventions

Implantation of the VADLINK Percutaneous Left Ventricular Assist Device

DEVICE

VA-ECMO

DEVICE

Contacts

Jun Jiang

CONTACT

+86 135 8870 6891 dyjayj@qq.com

ELEVATE High-Risk PCI Pivotal Study

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High-Risk Percutaneous Coronary Intervention (High-risk PCI)

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NOT_YET_RECRUITINGPHASE4

Trial of Low-intensity Anticoagulation to Reduce GI or Other Bleeding Complications With Equivalent Therapeutic Efficacy in HeartMate 3 LVAD Patients

NCT07081035

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Interventional Left Ventricular Assist System for PCI in CHIP Patients

Inclusion Criteria

Exclusion Criteria

ELEVATE High-Risk PCI Pivotal Study

Trial of Low-intensity Anticoagulation to Reduce GI or Other Bleeding Complications With Equivalent Therapeutic Efficacy in HeartMate 3 LVAD Patients

REVADE : Right Ventricular Function and Exercise in Left Ventricular Assist Device Patients : Echocardiographic Study