Actively Recruiting
Interventional Left Ventricular Assist System for PCI in CHIP Patients
Led by Suzhou Hengruihongyuan Medical Technology Co. LTD · Updated on 2025-08-26
286
Participants Needed
15
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Interventional Left Ventricular Assist System for PCI in CHIP Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 90 years
- Requires coronary revascularization but is considered high-risk for or refuses coronary artery bypass grafting (CABG)
- Left ventricular ejection fraction of 35% or less
- Coronary imaging showing any of the following: unprotected left main artery disease (stenosis ≥ 50%), last remaining patent coronary artery, saphenous vein graft lesions, severe calcification or tortuosity, multivessel disease with chronic total occlusion, or three-vessel disease
- Ability to give informed consent and complete follow-up
You will not qualify if you...
- Cardiogenic shock within the last 7 days
- Recent STEMI or elevated CK-MB not normalized within 24 hours
- Cardiac arrest with resuscitation within 24 hours
- Left ventricular mural thrombus
- History of aortic valve replacement surgery
- Use of ECMO or percutaneous ventricular assist device within 7 days
- Moderate to severe aortic valve disease
- Heart defects such as septal defects or post-infarction ruptures
- Severe right heart failure or tricuspid valve insufficiency
- Aortic disease interfering with procedure, including Marfan syndrome or aneurysm
- Severe peripheral arterial stenosis or occlusive disease
- Moderate or severe anemia or abnormal coagulation
- Known allergies or contraindications to heparin, contrast agents, or study medications
- Active bleeding within 1 month
- Stroke, transient ischemic attack, or permanent neurologic deficits within 1 month
- Severe kidney or liver dysfunction
- Infection or suspected infective endocarditis
- Pregnant, breastfeeding, or planning pregnancy
- Participation in another clinical trial
- Other conditions deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China, 102218
Not Yet Recruiting
2
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, China, 361004
Not Yet Recruiting
3
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
Not Yet Recruiting
4
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Not Yet Recruiting
5
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, China, 510515
Not Yet Recruiting
6
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
7
People's Hospital of Hunan Province
Changsha, Hunan, China, 410005
Not Yet Recruiting
8
Suzhou Municipal Hospital
Suzhou, Jiangsu, China, 215002
Not Yet Recruiting
9
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
10
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
11
The People's Hospital of Liaoning Province
Shenyang, Liaining, China, 110015
Not Yet Recruiting
12
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
13
Zhejiang Hospital
Hangzhou, Zhejiang, China, 310013
Not Yet Recruiting
14
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315000
Not Yet Recruiting
15
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Not Yet Recruiting
Research Team
J
Jun Jiang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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