Coronary Artery DiseaseNCT06754839
Clinical Trial of Ventiflow LP Supporting High-risk Percutaneous Coronary Intervention(PCI)
A study testing Percutaneous left ventricular assist device(Ventiflow LP) and VA-ECMO in people with Coronary Artery Disease and Heart Failure, run by Suzhou Hearthill Medical Technology Co.,LTD.
Trial summary
The purpose of this prospective, multicenter, randomized controlled clinical trial is to evaluate the effectiveness of the transcatheter left ventricular assist system (Ventiflow LP) in providing circulatory support to patients during high-risk PCI procedures compared to veno-arterial extracorporeal membrane… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease, Heart Failure, High-risk PCI
- What is being tested?
- Percutaneous left ventricular assist device(Ventiflow LP) and VA-ECMO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Dec 2025
- 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
- 18 Years to 90 Years
- The cardiac team determined that the subject needs coronary artery revascularization, but there is a higher risk of CABG, or the subject refuses to accept CABG. After comprehensive evaluation by the cardiac team, it was determined that the subjects could benefit from PCI
- The subject is diagnosed with acute or chronic coronary syndrome, and
- LVEF≤ 35% or
- LVEF ≤ 40% and NYHA Classification is III or IV
- Informed consent
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- The participant meets all the above clinical inclusion criteria and must comply with at least one of the following imaging criteria.
- 1. At least two coronary artery CTOs (diameter of occluded artery ≥ 2.5mm) 2. Unprotected left main coronary artery disease, and meeting one or more complex operating standards 3. Three-vessel disease and meeting two or more complex operating standards
- Complex operations are defined as:
- Bifurcation lesions require treatment of dual branches (including stents and PTCA)
- Calcification lesions require complex operation or instrument assistance (Excimer laser coronary atherectomy, intravascular lithotripsy, or rotational atherectomy)
- Severe distortion requires complex operations
- The target lesion is CTO (diameter of occluded artery ≥ 2.5mm and J-CTO score ≥ 2 )
Who cannot join
- Acute ST-elevation myocardial infarction within 7 days or receiving thrombolytic therapy;
- Cardiopulmonary resuscitation within 24 hours;
- Patients who have had cardiogenic shock (systolic blood pressure < 90 mmHg for more than 30 minutes or need catecholamines to maintain systolic blood pressure above 90 mmHg) or hemodynamic instability within 7 days before surgery;
- Atrial or ventricular septal defect (including post-infarct VSD), left ventricular wall thrombus; left ventricular rupture, cardiac tamponade, or concomitant cardiopulmonary failure;
- Presence of aortic stenosis/calcification (aortic orifice area ≤ 0.6cm2), documented moderate to severe aortic regurgitation (echocardiographic assessment grade ≥2+); have an artificial aortic valve;
- Severe pulmonary hypertension, right heart failure or severe tricuspid regurgitation;
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- Prior or current use of a persistent left ventricular assist device (LVAD), or use of IABP, extracorporeal membrane oxygenation (ECMO), or percutaneous ventricular assist device (such as Impella or Tandem Heart) within 7 days prior to surgery;
- History of stroke or transient ischemic attack within 1 month before surgery;
- Patients with renal failure (creatinine ≥3 times ULN) and may require dialysis treatment;
- Subject has abnormal liver function (elevated aspartate aminotransferase (AST), alanine aminotransferase (ALT) and bilirubin levels ≥3 times ULN);
- Moderate and severe anemia (hemoglobin <90g/L); Subject has abnormalities in coagulation parameters that cannot be corrected (defined as platelet count ≤ 75×109/L or INR ≥2.0 or fibrinogen ≤1.50g/l); or inability to be treated with antiplatelet agents and anticoagulants;
- Active visceral hemorrhage within 1 month;
- History of allergy to heparin, contrast media, etc.;
- Aortic abnormalities that preclude surgery, including aneurysms, extreme curvature, or calcification; or known severe arterial disease that precludes the trial, such as aortic dissection, Marfan syndrome, etc.;
- Severe peripheral arterial obstructive disease (stent, tortuosity, stenosis, dissection, etc.) that prevents study device placement;
- Infection at the site of the planned surgical puncture site or suspected active systemic infection with fever or need for antibiotic therapy;
- Pregnant women and lactating women;
- The subject has participated in other medical device clinical trials/drug clinical trials during the same period;
- ECMO cannot be implanted or there are contraindications to its application and any other conditions that the investigator considers inappropriate to participate in this trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Trial Evaluating the Effectiveness and Safety of Percutaneous Left Ventricular Assist Device in Supporting High-risk Percutaneous Coronary Intervention
The purpose of this prospective, multicenter, randomized controlled clinical trial is to evaluate the effectiveness of the transcatheter left ventricular assist system (Ventiflow LP) in providing circulatory support to patients during high-risk PCI procedures compared to veno-arterial extracorporeal membrane oxygenation (VA-ECMO).The participants will be randomly assigned to the experimental group or the control group after enrollment, and will undergo percutaneous coronary intervention(PCI) with support from Ventiflow LP or VA-ECMO respectively. All participants need to undergo a 3-month follow-up after operative.
- Conditions
- Coronary Artery Disease, Heart Failure, High-risk PCI
- Being tested
- Percutaneous left ventricular assist device(Ventiflow LP), VA-ECMO
- Keywords
- High-risk PCI, Percutaneous left ventricular assist device, heart failure
- Medical subject headings
- Coronary Artery Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous left ventricular assist device(Ventiflow LP)Device
The PCI will be completed with the support of percutaneous left ventricular assist device(Ventiflow LP).
VA-ECMODevice
The PCI will be completed with the support of Veno-arterial extracorporeal membrane oxygenation (VA-ECMO).
| Study group | Role | What they receive |
|---|---|---|
| Experimental group(Ventiflow LP) | Experimental | Not described Receives: Device: Percutaneous left ventricular assist device(Ventiflow LP) |
| Control Group(VA-ECMO) | Active comparator | Not described Receives: Device: VA-ECMO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse events within 30 days post-operation.
Major adverse events are defined as death, stroke, myocardial infarction, revascularization, rehospitalization due to cardiovascular reasons, bleeding types 3, 4, 5 defined by mechanical circulatory support academic research consortium (MCS-ARC) , acute kidney injury, serious device-related adverse events, cardiopulmonary resuscitation.
Measured: 30 days post-operation
Secondary outcomes (17)
Incidence of major adverse events within 90 days post-operation.
Measured: 90 days post-operation
Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days post-operation.
MACCE is defined as all-cause mortality, myocardial infarction, stroke, and any subsequent revascularization procedures .
Measured: 30 days post-operation
Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 90 days post-operation.
MACCE is defined as all-cause mortality, myocardial infarction, stroke, and any subsequent revascularization procedures .
Measured: 90 days post-operation
Success rate of hemodynamic support during device use
definition of successful hemodynamic support: successful delivery and initiation of the device, no hemodynamic deregulation occurs during the device support period (haemodynamic derangement refers to: mean arterial pressure(MAP ) less than 60 mmHg for more than 10 minutes and requires additional vasoactive drug therapy)
Measured: 90 days post-operation
The success rate of percutaneous coronary intervention(PCI)
The success rate of PCI is defined as: residual stenosis < 30% after stent implantation or < 50% after balloon angioplasty, or thrombolysis in myocardial infarction(TIMI) flow grade 3.
Measured: 90 days post-operation
Complete revascularization rate
Complete revascularization rate is defined as: residual SYNTAX score ≤8
Measured: Immediately after the intervention
Change in creatinine clearance
Measured: Baseline to 48 hours postoperation and 30 days post-operation
The change in left ventricular ejection fraction (LVEF) compared to baseline
Measured: Baseline to 30 days post-operation and 90 days post-operation
The change in New York heart association(NYHA) classification compared to baseline
The NYHA classification of heart function consists of four levels, ranging from I to IV, with heart function progressively deteriorating.
Measured: 30 days post-operation, 90 days post-operation
Length of hospital stay within 30 days post-operation
Measured: 30 days post-operation
Length of intensive care unit(ICU)/(coronary care unit)CCU stay within 30 days post-operation
Measured: 30 days post-operation
Success rate of device operation
The system has delivered to the designated position and completed the pump start-up without any device failure.
Measured: 30 days post-operation
Usage time of research device
The time from the start to the stop of the research device.
Measured: 30 days post-operation
Device performance evaluation
The operator scores the device after use, with 5 being the best and 1 being the worst.
Measured: Intraoperation
The failure rate of the device
The failure rate of the device is defined as any component of the research equipment (Ventiflow LP or ECMO) system that is unable to operate according to its designed performance specifications .
Measured: Intraoperation
Incidence of serious adverse events
Incidence of serious adverse events: Serious adverse events refer to those that occur during the clinical trial process and result in death or a significant deterioration in health status, including fatal diseases or injuries, permanent impairment of bodily structure or function, and events that require medical or surgical intervention to prevent permanent impairment of bodily structure or function, among others.
Measured: 90 days post-operation
The incidence of serious adverse events
The incidence of serious adverse events related to medical devices: including but not limited to cardiac structural damage, severe limb ischemia (pallor, pulselessness, and necrosis), infections, damage to the aorta and aortic valve, hemolysis, complications requiring surgical intervention, and events leading to subject mortality, permanent or severe disability, significantly prolonged hospitalization, or the need for surgical intervention .
Measured: 90 days post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study startDec 2024 (estimated)
- Primary completionOct 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yujie Zhou, MD, Study chair, Beijing Anzhen HospitalYong He, MD, Study chair, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754839
- Sponsor's protocol ID
- XLMD-ZSFZ-QX02
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- 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 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial Evaluating the Effectiveness and Safety of Percutaneous Left Ventricular Assist Device in Supporting High-risk Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06754839
- Acronym / sponsor ID
- XLMD-ZSFZ-QX02
- Conditions
- Coronary Artery Disease, Heart Failure, High-risk PCI
- Keywords
- High-risk PCI, Percutaneous left ventricular assist device, heart failure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Suzhou Hearthill Medical Technology Co.,LTDIndustry (pharma, biotech, devices)
- Study start
- Dec 2024 (estimated)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 1 Jan 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.
The purpose of this prospective, multicenter, randomized controlled clinical trial is to evaluate the effectiveness of the transcatheter left ventricular assist system (Ventiflow LP) in providing circulatory support to patients during high-risk PCI procedures compared to veno-arterial extracorporeal membrane oxygenation (VA-ECMO).The participants will be randomly assigned to the experimental group or the control group after enrollment, and will undergo percutaneous coronary intervention(PCI) with support from Ventiflow LP or VA-ECMO respectively. All participants need to undergo a 3-month follow-up after operative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group(Ventiflow LP) | Experimental | Device: Percutaneous left ventricular assist device(Ventiflow LP) |
| Control Group(VA-ECMO) | Active comparator | Device: VA-ECMO |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 18 Years to 90 Years
- The cardiac team determined that the subject needs coronary artery revascularization, but there is a higher risk of CABG, or the subject refuses to accept CABG. After comprehensive evaluation by the cardiac team, it was determined that the subjects could benefit from PCI
- The subject is diagnosed with acute or chronic coronary syndrome, and
- Informed consent
- The participant meets all the above clinical inclusion criteria and must comply with at least one of the following imaging criteria.
Key exclusion criteria (19 listed)
- Acute ST-elevation myocardial infarction within 7 days or receiving thrombolytic therapy;
- Cardiopulmonary resuscitation within 24 hours;
- Patients who have had cardiogenic shock (systolic blood pressure < 90 mmHg for more than 30 minutes or need catecholamines to maintain systolic blood pressure above 90 mmHg) or hemodynamic instability within 7 days before surgery;
- Atrial or ventricular septal defect (including post-infarct VSD), left ventricular wall thrombus; left ventricular rupture, cardiac tamponade, or concomitant cardiopulmonary failure;
- Presence of aortic stenosis/calcification (aortic orifice area ≤ 0.6cm2), documented moderate to severe aortic regurgitation (echocardiographic assessment grade ≥2+); have an artificial aortic valve;
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 |
|---|---|---|
| Percutaneous left ventricular assist device(Ventiflow LP)The PCI will be completed with the support of percutaneous left ventricular assist device(Ventiflow LP). | Device | Experimental group(Ventiflow LP) |
| VA-ECMOThe PCI will be completed with the support of Veno-arterial extracorporeal membrane oxygenation (VA-ECMO). | Device | Control Group(VA-ECMO) |
Primary outcome
Incidence of major adverse events within 30 days post-operation.
Time frame: 30 days post-operation
Major adverse events are defined as death, stroke, myocardial infarction, revascularization, rehospitalization due to cardiovascular reasons, bleeding types 3, 4, 5 defined by mechanical circulatory support academic research consortium (MCS-ARC) , acute kidney injury, serious device-related adverse events, cardiopulmonary resuscitation.
17 secondary outcomes
Incidence of major adverse events within 90 days post-operation.
Time frame: 90 days post-operation
Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days post-operation.
Time frame: 30 days post-operation
Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 90 days post-operation.
Time frame: 90 days post-operation
Success rate of hemodynamic support during device use
Time frame: 90 days post-operation
The success rate of percutaneous coronary intervention(PCI)
Time frame: 90 days post-operation
Complete revascularization rate
Time frame: Immediately after the intervention
Change in creatinine clearance
Time frame: Baseline to 48 hours postoperation and 30 days post-operation
The change in left ventricular ejection fraction (LVEF) compared to baseline
Time frame: Baseline to 30 days post-operation and 90 days post-operation
The change in New York heart association(NYHA) classification compared to baseline
Time frame: 30 days post-operation, 90 days post-operation
Length of hospital stay within 30 days post-operation
Time frame: 30 days post-operation
Length of intensive care unit(ICU)/(coronary care unit)CCU stay within 30 days post-operation
Time frame: 30 days post-operation
Success rate of device operation
Time frame: 30 days post-operation
Usage time of research device
Time frame: 30 days post-operation
Device performance evaluation
Time frame: Intraoperation
The failure rate of the device
Time frame: Intraoperation
Incidence of serious adverse events
Time frame: 90 days post-operation
The incidence of serious adverse events
Time frame: 90 days post-operation
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 1 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Yujie Zhou, MD study chair
Beijing Anzhen Hospital
Yong He, MD study chair
West China Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous left ventricular assist device(Ventiflow LP) and VA-ECMO in people with Coronary Artery Disease and Heart Failure, run by Suzhou Hearthill Medical Technology Co.,LTD.
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 13 inclusion and 19 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: opening soon, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Yujie Zhou, MD (086-13901330652, azzyj12@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse events within 30 days post-operation. (time frame: 30 days post-operation). 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 1 Jan 2025.