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Coronary Artery DiseaseNCT06639321

Phimume® Percutaneous Left Ventricular Assist System Study

A study testing Percutaneous Ventricular Assist System and extracorporeal membrane oxygenation (ECMO) in people with Coronary Artery Disease, run by Shanghai NewMed Medical Co., Ltd. at 6 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus extracorporeal membrane oxygenation (ECMO) 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 and extracorporeal membrane oxygenation (ECMO)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
6 sitesChina
Study dates
14 Oct 2024to 14 Oct 2026
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 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.);
  • Severe pulmonary artery hypertension (pulmonary artery systolic pressure >70 mmHg);
  • 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

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yang Xu contact

+86 021-20788668

xu_yang@newmed.cn

6 sites in 1 country

China6 sites

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

    Shenghua Zhou

  • West China Hospital, Sichuan University

    Chengdu, Chengdu

    Mao Chen

  • The Second Hospital of Jilin University

    Jilin City, Changchun

    Bin Liu

  • 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

Other trials in China

About this study

Official title: The Safety and Efficacy of the Percutaneous Left Ventricular Assist System Versus ECMO 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 extracorporeal membrane oxygenation (ECMO) 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.

Being tested
Percutaneous Ventricular Assist System, extracorporeal membrane oxygenation (ECMO)
Keywords
Percutaneous Ventricular Assist System, high-risk PCI
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 SystemDevice

    Percutaneous Ventricular Assist System provides intraoperative circulatory support during high-risk PCI.

  • extracorporeal membrane oxygenation (ECMO)Device

    ECMO provides intraoperative circulatory support during high-risk PCI.

Study groups in NCT06639321
Study groupRoleWhat they receive
percutaneous left ventricular assist systemExperimentalSubjects 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
extracorporeal membrane oxygenation (ECMO)Active comparatorSubjects with coronary artery disease receiving high-risk PCI will be supported by ECMO during the procedure.
Receives: Device: extracorporeal membrane oxygenation (ECMO)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 (16)

  1. Incidence of death

    Rate of all-cause death during the trial.

    Measured: 30 days, 90 days after procedure

  2. Incidence of myocardial infarction

    Rate of patients with myocardial infarction during the trial.

    Measured: 30 days, 90 days after procedure

  3. Incidence of stroke

    Rate of patients with stroke during the trial.

    Measured: 30 days, 90 days after procedure

  4. Incidence of target vessel revascularization

    Rate of patients with target vessel revascularization during the trial.

    Measured: 30 days, 90 days after procedure

  5. 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

  6. Incidence of acute kidney injury Remove

    Rate of patients with acute kidney injury during the trial.

    Measured: 30 days, 90 days after procedure

  7. 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

  8. 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

  9. 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

  10. 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

  11. Hemodynamic support success rate during PCI procedure

    Hemodynamic support success is defined as (1) Percutaneous mechanical circulatory assist device was delivered and activated successfully, and withdrawn from the body successfully; (2) 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

  12. 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: mmediately after procedure

  13. Procedural success rate

    Procedure success is defined as (1) Technical success; (2) Freedom from serious in-hospital procedural complications

    Measured: Immediately after procedure

  14. 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

  15. 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

  16. 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.

  1. First posted15 Oct 2024
  2. Study start14 Oct 2024 (estimated)
  3. Primary completion14 Nov 2025 (estimated)
  4. Study completion14 Oct 2026 (estimated)

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06639321
Sponsor's protocol ID
Phimume -2024
Status last verified
Oct 2024
First submitted
10 Oct 2024
Last updated
15 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Percutaneous Ventricular Assist System and extracorporeal membrane oxygenation (ECMO) in people with Coronary Artery Disease, run by Shanghai NewMed Medical Co., Ltd. at 6 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 20 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 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?

On the ClinicalTrials.gov record for NCT06639321.

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 15 Oct 2024.

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Clinical Trial NCT06639321 | AzTrials