Coronary Artery DiseaseNCT06357026
Phitys I™ Percutaneous Left Ventricular Assist System Study
A study testing Percutaneous Ventricular Assist System（Phigine Medical） and intra-aortic balloon pump (IABP) in people with Coronary Artery Disease, run by Shanghai NewMed Medical Co., Ltd. at 8 sites in China.
Trial summary
The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus intra-aortic balloon pump (IABP) for Circulatory Support during High-risk PCI. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Percutaneous Ventricular Assist System（Phigine Medical） and intra-aortic balloon pump (IABP)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 344 participants
- Where
- 8 sitesChina
- Study dates
- 1 Apr 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 old≤ patient age ≤90 years old AND patient is not in pregnancy or lactation;
- Patients who have been evaluated by two or more cardiovascular surgeons as unsuitable for conventional surgery; or patients who have refused conventional surgery after adequate communication from the surgeon and who are at high risk for conventional surgery;
- Left Ventricular Ejection Fraction (LVEF) ≤ 35% AND at least one of the following criteria:
- Intervention on the last patent coronary conduit, or
- Intervention on an unprotected left main coronary artery Or b) LVEF ≤ 30% and intervention in patient presenting with triple vessel disease.
- Patient who can understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.
Who cannot join
- Pre-procedure cardiac arrest within 24 hours of enrolment requiring CPR;
- Pre-procedure ST-segment myocardial infarction within 24 hours of enrolment;
- Patient is in cardiogenic shock;
- Mural thrombus in the left ventricle;
- Post-infarction ventricular septal rupture, or atrial septal or ventricular septal defects;
- The presence of mechanical aortic or mitral valve or heart constrictive device;
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- The presence of aortic stenosis (aortic orifice area ≤1.5cm²)；
- The presence of moderate to severe aortic or mitral or tricuspid insufficiency;
- The presence of severe peripheral vascular disease that would preclude the placement of the percutaneous mechanical circulatory assist device;
- Severe aortic diseases such as aortic dissection and aortic aneurysm;
- Active infective endocarditis or other active infections;
- Chronic renal insufficiency (creatinine clearance≤30ml/min);
- Liver dysfunction (elevation of liver enzymes and bilirubin levels to ≥3xULN or INR≥2);
- The presence of uncorrectable abnormal coagulation (platelet count≤75,000/mm^3 or INR≥2.0 or fibrinogen≤1.50 g/l);
- The presence of uncorrected moderate to severe anemia (hemoglobin <90 g/L);
- History of stroke or TIA within 1 month of enrolment;
- Allergy or intolerance to contrast media, anticoagulant and antiplatelet drugs (e.g., bivalirudin, low molecular heparin, aspirin, clopidogrel, Ticagrelor, etc.);
- Participation in clinical trials of other drugs or medical devices prior to enrollment that have not yet reached the primary outcome of research;
- Patient with poor compliance and could not complete the study as required determined by the investigator.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Shenghua Zhou
West China Hospital, Sichuan University
Chengdu, Sichuan
Mao Chen
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Yue Li
The Second Hospital of Jilin University
Jilin City, Changchun
Bin Liu
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Li Zhang
General Hospital of Northern Theater Command
Shenyang, Liaoning
Yaling Han
Renmin Hospital of Wuhan University
Wuhan, Hubei
Hong Jiang
Henan Provincial Chest Hospital
Zhengzhou, Henan
Yiqiang Yuan
About this study
Official title: The Safety and Efficacy of the Percutaneous Left Ventricular Assist System for Intraoperative Circulatory Support During High-risk Percutaneous Coronary Intervention (PCI): a Prospective, Multi-center, Randomized Controlled Study
The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus intra-aortic balloon pump (IABP) for Circulatory Support during High-risk PCI.
Read the detailed description
This prospective, multi-center, randomized controlled clinical trial of the Percutaneous Ventricular Assist System is designed to measure the incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days after PCI.
- Conditions
- Coronary Artery Disease
- Being tested
- Percutaneous Ventricular Assist System（Phigine Medical）, intra-aortic balloon pump (IABP)
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Ventricular Assist System（Phigine Medical）Device
Percutaneous Ventricular Assist System or IABP provides intraoperative circulatory support during high-risk PCI.
intra-aortic balloon pump (IABP)Device
IABP provides intraoperative circulatory support during high-risk PCI.
| Study group | Role | What they receive |
|---|---|---|
| percutaneous left ventricular assist system | Experimental | Subjects with coronary artery disease receiving high-risk PCI will be supported by Percutaneous Ventricular Assist System during the procedure. Receives: Device: Percutaneous Ventricular Assist System（Phigine Medical） |
| intra-aortic balloon pump (IABP) | Active comparator | Subjects with coronary artery disease receiving high-risk PCI will be supported by IABP during the procedure. Receives: Device: intra-aortic balloon pump (IABP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE)
MACCE defined as death, myocardial infarction, stroke, and target vessel revascularization.
Measured: 30 days after procedure
Secondary outcomes (17)
Incidence of death
Rate of all-cause death during the trial.
Measured: 30 days, 90 days after procedure
Incidence of myocardial infarction
Rate of patients with myocardial infarction during the trial.
Measured: 30 days, 90 days after procedure
Incidence of stroke
Rate of patients with stroke during the trial.
Measured: 30 days, 90 days after procedure
Incidence of target vessel revascularization
Rate of patients with target vessel revascularization during the trial.
Measured: 30 days, 90 days after procedure
Incidence of need for cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia
Rate of patients with unplanned cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia during the trial.
Measured: 30 days, 90 days after procedure
Incidence of acute kidney injury
Rate of patients with acute kidney injury during the trial.
Measured: 30 days, 90 days after procedure
Incidence of cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion
Rate of patients with cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion during the trial.
Measured: 30 days, 90 days after procedure
Incidence of increasing in aortic insufficiency by more than one grade
Rate of patients with increasing in aortic insufficiency by more than one grade during the trial.
Measured: 30 days, 90 days after procedure
Incidence of severe hypotension
Rate of patients with severe hypotension during the trial. Severe hypotension defined as systolic blood pressure or augmented diastolic pressure (whichever is greater) <90 mmHg for ≥5 min requiring inotropic/pressor medications or IV fluid.
Measured: 30 days, 90 days after procedure
Incidence of failure to achieve angiographic success
Rate of failure to achieve angiographic success during the trial. Angiographic success defined as residual stenosis <30% after stent implantation.
Measured: 30 days, 90 days after procedure
Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE)
Rate of patients with freedom from major adverse cardiovascular and cerebrovascular events (MACCE) during the trial.
MACCE defined as death, myocardial infarction, stroke, and target vessel revascularization.
Measured: 90 days after procedure
Hemodynamic support success rate during PCI procedure
Hemodynamic support success is defined as
- Percutaneous mechanical circulatory assist device was delivered and activated successfully, and withdrawn from the body successfully;
- Hemodynamic stability during procedure (defined as mean arterial pressure (MAP) <60mmHg for no more than 10 minutes during the PCI procedure and additional pressor medication is not required).
Measured: During procedure
Technical success rate
Technical success is defined as (1) Hemodynamic support success; (2) Coronary revascularization success (defined as ①residual stenosis <30% after coronary stent implantation; ②restoration of TIMI anterograde flow of II or III).
Measured: Immediately after procedure
Procedural success rate
Procedure success is defined as (1) Technical success; (2) Freedom from serious in-hospital procedural complications
Measured: Immediately after procedure
Change in LVEF compared to baseline
LVEF is assessed at 30 days, 90 days after procedure, and compared to baseline.
Measured: 30 days, 90 days after procedure
Improvement in cardiac function
Cardiac function is evaluated based on NYHA classification and compared to baseline.
New York Heart Association (NYHA) Functional Classification includes four categories(CLASS I to CLASS IV, higher class mean a worse outcome) based on physical activity limitations.
Measured: 30 days, 90 days after procedure
Evaluation of Experimental device performance
Performance evaluation includes the catheter pump and extracorporeal control device (For each assessment: 1-10 points；1=worst, 5=moderate, 10=best).
Measured: Immediately after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Apr 2026 (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
- 344 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai NewMed Medical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Phigine Medical Technology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Yaling Han, Principal investigator, The General Hospital of Northern Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357026
- Sponsor's protocol ID
- Phitys I -2024
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of the Percutaneous Left Ventricular Assist System for Intraoperative Circulatory Support During High-risk Percutaneous Coronary Intervention (PCI): a Prospective, Multi-center, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06357026
- Acronym / sponsor ID
- Phitys I -2024
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 344 participants (estimated)
- Lead sponsor
- Shanghai NewMed Medical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Phigine Medical Technology Co., Ltd.
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 10 Apr 2024 (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 primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus intra-aortic balloon pump (IABP) for Circulatory Support during High-risk PCI.
Detailed description
This prospective, multi-center, randomized controlled clinical trial of the Percutaneous Ventricular Assist System is designed to measure the incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days after PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| percutaneous left ventricular assist system | Experimental | Device: Percutaneous Ventricular Assist System（Phigine Medical）Subjects with coronary artery disease receiving high-risk PCI will be supported by Percutaneous Ventricular Assist System during the procedure. |
| intra-aortic balloon pump (IABP) | Active comparator | Device: intra-aortic balloon pump (IABP)Subjects with coronary artery disease receiving high-risk PCI will be supported by IABP during the procedure. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years old≤ patient age ≤90 years old AND patient is not in pregnancy or lactation;
- Patients who have been evaluated by two or more cardiovascular surgeons as unsuitable for conventional surgery; or patients who have refused conventional surgery after adequate communication from the surgeon and who are at high risk for conventional surgery;
- Left Ventricular Ejection Fraction (LVEF) ≤ 35% AND at least one of the following criteria:
- Patient who can understand the purpose of the trial and volunteer to participate in, sign the informed consent form and are willing to accept relevant examinations and clinical follow-ups.
Key exclusion criteria (19 listed)
- Pre-procedure cardiac arrest within 24 hours of enrolment requiring CPR;
- Pre-procedure ST-segment myocardial infarction within 24 hours of enrolment;
- Patient is in cardiogenic shock;
- Mural thrombus in the left ventricle;
- Post-infarction ventricular septal rupture, or atrial septal or ventricular septal defects;
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 Ventricular Assist System（Phigine Medical）Percutaneous Ventricular Assist System or IABP provides intraoperative circulatory support during high-risk PCI. | Device | percutaneous left ventricular assist system |
| intra-aortic balloon pump (IABP)IABP provides intraoperative circulatory support during high-risk PCI. | Device | intra-aortic balloon pump (IABP) |
Primary outcome
Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: 30 days after procedure
MACCE defined as death, myocardial infarction, stroke, and target vessel revascularization.
17 secondary outcomes
Incidence of death
Time frame: 30 days, 90 days after procedure
Incidence of myocardial infarction
Time frame: 30 days, 90 days after procedure
Incidence of stroke
Time frame: 30 days, 90 days after procedure
Incidence of target vessel revascularization
Time frame: 30 days, 90 days after procedure
Incidence of need for cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia
Time frame: 30 days, 90 days after procedure
Incidence of acute kidney injury
Time frame: 30 days, 90 days after procedure
Incidence of cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion
Time frame: 30 days, 90 days after procedure
Incidence of increasing in aortic insufficiency by more than one grade
Time frame: 30 days, 90 days after procedure
Incidence of severe hypotension
Time frame: 30 days, 90 days after procedure
Incidence of failure to achieve angiographic success
Time frame: 30 days, 90 days after procedure
Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: 90 days after procedure
Hemodynamic support success rate during PCI procedure
Time frame: During procedure
Technical success rate
Time frame: Immediately after procedure
Procedural success rate
Time frame: Immediately after procedure
Change in LVEF compared to baseline
Time frame: 30 days, 90 days after procedure
Improvement in cardiac function
Time frame: 30 days, 90 days after procedure
Evaluation of Experimental device performance
Time frame: Immediately after procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
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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. This study is not recruiting at the moment.
Yaling Han principal investigator
The General Hospital of Northern Theater Command
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Ventricular Assist System（Phigine Medical） and intra-aortic balloon pump (IABP) in people with Coronary Artery Disease, run by Shanghai NewMed Medical Co., Ltd. at 8 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 6 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: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Xu (+86 021-20788668, xu_yang@newmed.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE) (time frame: 30 days after procedure). 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 10 Apr 2024.