High-Risk Percutaneous Coronary Intervention (High-risk PCI)NCT07053618
Interventional Left Ventricular Assist System for PCI in CHIP Patients
A study testing Implantation of the VADLINK Percutaneous Left Ventricular Assist Device and VA-ECMO in people with High-Risk Percutaneous Coronary Intervention (High-risk PCI) and Left Ventricular Assist Devices, run by Suzhou Hengruihongyuan Medical Technology Co. LTD at 15 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- High-Risk Percutaneous Coronary Intervention (High-risk PCI), Left Ventricular Assist Devices
- What is being tested?
- Implantation of the VADLINK Percutaneous Left Ventricular Assist Device and VA-ECMO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 15 sitesChina
- Study dates
- 6 Aug 2025to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
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- 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.
- 5. Patients who are able to give informed consent and complete the follow-up.
Who cannot join
- 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.
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- 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.
- Renal dysfunction: subject on dialysis or serum creatinine ≥4 mg/dL (353.6 µmol/L) within 7 days.
- Liver dysfunction: liver AST, ALT and bilirubin >3 times the upper limit of normal within 7 days.
- Presence or suspected presence of infective endocarditis or systemic infection.
- Women who are pregnant, breastfeeding, or planning pregnancy during the trial.
- Participation in another drug or medical device clinical trial.
- Other conditions deemed by the investigator as unsuitable for participation in this trial.
- -
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Not yet recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218
Ping Zhang
Ping Zhang
- Not yet recruiting
People's Hospital of Hunan Province
Changsha, Hunan, 410005
Hongwei Pan
Hongwei Pan
- Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Chengbin Zhou
Chengbin Zhou
- Not yet recruiting
Nanfang Hospital Southern Medical University
Guangzhou, Guangdong, 510515
Jiancheng Xiu
Jiancheng Xiu
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jun Jiang, 135 8870 6891, dyjayj@qq.com
Jun Jiang
- Not yet recruiting
Zhejiang Hospital
Hangzhou, Zhejiang, 310013
Wei Mao
Wei Mao
- Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Ming Bai
Ming Bai
- Not yet recruiting
Jiangxi Provincial People's Hospital
Nanchang, Jiangxi, 330006
Hengli Lai
Hengli Lai
- Not yet recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Xiaoping Peng
Xiaoping Peng
- Not yet recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315000
Xiaomin Chen
Xiaomin Chen
- Not yet recruiting
The People's Hospital of Liaoning Province
Shenyang, Liaining, 110015
Bo Luan
Bo Luan
- Not yet recruiting
Suzhou Municipal Hospital
Suzhou, Jiangsu, 215002
Yan Chen
Yan Chen
- Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Hao Zhou
Hao Zhou
- Not yet recruiting
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, 361004
Huiheng Liu
Huiheng Liu
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Chunguang Qiu
Chunguang Qiu
About this study
Official title: Interventional Left Ventricular Assist System for PCI in CHIP Patients: a Prospective, Multicenter, Noninferiority Randomized Controlled Trial
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.
Read more
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
- Being tested
- Implantation of the VADLINK Percutaneous Left Ventricular Assist Device, VA-ECMO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of the VADLINK Percutaneous Left Ventricular Assist DeviceDevice
To implant VADLINK percutaneous left ventricular assist device during percutaneous coronary intervention (PCI).
VA-ECMODevice
Received venous arterial extracorporeal membrane oxygenation (VA-ECMO) during PCI.
| Study group | Role | What they receive |
|---|---|---|
| VADLINK | Experimental | The VADLINK percutaneous left ventricular assist system will offer intraoperative hemodynamic support during high-risk PCI procedures. Receives: 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. Receives: Device: VA-ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 30 ±7 days after PCI surgery
Secondary outcomes (10)
The MACCE rate
Incidence of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) within 30 or 90 days after surgery.
Measured: 30, 90 days
Transfusion rate
Transfusion rate within 30 days after surgery.
Measured: 30 days
Mean units transfused
Mean Number of Blood Units Transfused within 30 Days Postoperatively.
Measured: 30 days
Incidence of hemodynamic instability
Incidence of hemodynamic instability within 30 days device implantation.
Measured: 30 days
90-day Major Adverse Events (MAE) rate
Measured: 90 days
Incidence of device-related adverse events
Measured: Implant up through 90 days
Incidence of device-related serious adverse events
Measured: Implant up through 90 days
Incidence of adverse events
Measured: Implant up through 90 days
Serious adverse event incidence rate
Measured: Implant up through 90 days
Incidence of device defects
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start6 Aug 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Risk Percutaneous Coronary Intervention (High-risk PCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053618
- Sponsor's protocol ID
- CVAD2.0
- Status last verified
- Aug 2025
- First submitted
- 23 Jun 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Left Ventricular Assist System for PCI in CHIP Patients: a Prospective, Multicenter, Noninferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07053618
- Acronym / sponsor ID
- CVAD2.0
- Conditions
- High-Risk Percutaneous Coronary Intervention (High-risk PCI), Left Ventricular Assist Devices
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Suzhou Hengruihongyuan Medical Technology Co. LTDIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VADLINK | Experimental | Device: Implantation of the VADLINK Percutaneous Left Ventricular Assist DeviceThe VADLINK percutaneous left ventricular assist system will offer intraoperative hemodynamic support during high-risk PCI procedures. |
| V-A ECMO | Active comparator | Device: VA-ECMOThe VA-ECMO offers intraoperative hemodynamic support during high-risk PCI procedures. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (22 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantation of the VADLINK Percutaneous Left Ventricular Assist DeviceTo implant VADLINK percutaneous left ventricular assist device during percutaneous coronary intervention (PCI). | Device | VADLINK |
| VA-ECMOReceived venous arterial extracorporeal membrane oxygenation (VA-ECMO) during PCI. | Device | V-A ECMO |
Primary outcome
30-day Major Adverse Events (MAE) rate
Time frame: From enrollment to 30 ±7 days after PCI surgery
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.
10 secondary outcomes
The MACCE rate
Time frame: 30, 90 days
Transfusion rate
Time frame: 30 days
Mean units transfused
Time frame: 30 days
Incidence of hemodynamic instability
Time frame: 30 days
90-day Major Adverse Events (MAE) rate
Time frame: 90 days
Incidence of device-related adverse events
Time frame: Implant up through 90 days
Incidence of device-related serious adverse events
Time frame: Implant up through 90 days
Incidence of adverse events
Time frame: Implant up through 90 days
Serious adverse event incidence rate
Time frame: Implant up through 90 days
Incidence of device defects
Time frame: Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for High-Risk Percutaneous Coronary Intervention (High-risk PCI)
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ELEVATE High-Risk PCI Pivotal Study
High-Risk Percutaneous Coronary Intervention (High-risk PCI)
Not yet recruitingObservational study
CHIP-CC Registry: A Prospective Multicenter Registry of Complex High-Risk PCI in China
Coronary Artery Disease, High Risk PCI
Active, not recruiting
Interventional Ventricular Assist System for PCI in CHIP Patients
High-Risk Percutaneous Coronary Intervention (High-risk PCI), Left Ventricular Assist Devices
Not yet recruitingPhase 4
Genotype-Guided Abbreviated DAPT Versus Un-Guided De-escalation Therapy in Patients With ACS and HBR
Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), High Bleeding Risk
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantation of the VADLINK Percutaneous Left Ventricular Assist Device and VA-ECMO in people with High-Risk Percutaneous Coronary Intervention (High-risk PCI) and Left Ventricular Assist Devices, run by Suzhou Hengruihongyuan Medical Technology Co. LTD at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Jiang (+86 135 8870 6891, dyjayj@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day Major Adverse Events (MAE) rate (time frame: From enrollment to 30 ±7 days after PCI surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025; AzTrials last refreshed its copy on 2 Nov 2026.