Phitys I™ Percutaneous Left Ventricular Assist System Study

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06357026
• Other study ID #: Phitys I -2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: April 2024
• Source: Shanghai NewMed Medical Co., Ltd.
• Contact: Yang Xu
• Phone: +86 021-20788668
• Email: xu_yang[@]newmed.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 344
• Est. completion date: April 1, 2026
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. 18 years old= patient age =90 years old AND patient is not in pregnancy or lactation;

2. 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;

3. 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.

4. 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.

Exclusion Criteria:

1. Pre-procedure cardiac arrest within 24 hours of enrolment requiring CPR;

2. Pre-procedure ST-segment myocardial infarction within 24 hours of enrolment;

3. Patient is in cardiogenic shock;

4. Mural thrombus in the left ventricle;

5. Post-infarction ventricular septal rupture, or atrial septal or ventricular septal defects;

6. The presence of mechanical aortic or mitral valve or heart constrictive device;

7. The presence of aortic stenosis (aortic orifice area =1.5cm²);

8. The presence of moderate to severe aortic or mitral or tricuspid insufficiency;

9. The presence of severe peripheral vascular disease that would preclude the placement of the percutaneous mechanical circulatory assist device;

10. Severe aortic diseases such as aortic dissection and aortic aneurysm;

11. Active infective endocarditis or other active infections;

12. Chronic renal insufficiency (creatinine clearance=30ml/min);

13. Liver dysfunction (elevation of liver enzymes and bilirubin levels to =3xULN or INR=2);

14. The presence of uncorrectable abnormal coagulation (platelet count=75,000/mm^3 or INR=2.0 or fibrinogen=1.50 g/l);

15. The presence of uncorrected moderate to severe anemia (hemoglobin <90 g/L);

16. History of stroke or TIA within 1 month of enrolment;

17. Allergy or intolerance to contrast media, anticoagulant and antiplatelet drugs (e.g., bivalirudin, low molecular heparin, aspirin, clopidogrel, Ticagrelor, etc.);

18. Participation in clinical trials of other drugs or medical devices prior to enrollment that have not yet reached the primary outcome of research;

19. Patient with poor compliance and could not complete the study as required determined by the investigator.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Percutaneous Ventricular Assist System(Phigine Medical)
Percutaneous Ventricular Assist System or IABP provides intraoperative circulatory support during high-risk PCI.
• intra-aortic balloon pump (IABP)
IABP provides intraoperative circulatory support during high-risk PCI.

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	West China Hospital, Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang
China	The Second Hospital of Jilin University	Jilin	Changchun
China	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	General Hospital of Northern Theater Command	Shenyang	Liaoning
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Henan Provincial Chest Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai NewMed Medical Co., Ltd.	Shanghai Phigine Medical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE)	MACCE defined as death, myocardial infarction, stroke, and target vessel revascularization.	30 days after procedure
Secondary	Incidence of death	Rate of all-cause death during the trial.	30 days, 90 days after procedure
Secondary	Incidence of myocardial infarction	Rate of patients with myocardial infarction during the trial.	30 days, 90 days after procedure
Secondary	Incidence of stroke	Rate of patients with stroke during the trial.	30 days, 90 days after procedure
Secondary	Incidence of target vessel revascularization	Rate of patients with target vessel revascularization during the trial.	30 days, 90 days after procedure
Secondary	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.	30 days, 90 days after procedure
Secondary	Incidence of acute kidney injury	Rate of patients with acute kidney injury during the trial.	30 days, 90 days after procedure
Secondary	Incidence of cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion	Rate of patients with cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion during the trial.	30 days, 90 days after procedure
Secondary	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.	30 days, 90 days after procedure
Secondary	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.	30 days, 90 days after procedure
Secondary	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.	30 days, 90 days after procedure
Secondary	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.	90 days after procedure
Secondary	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).	During procedure
Secondary	Technical success rate	Technical success is defined as (1) Hemodynamic support success; (2) Coronary revascularization success (defined as ?residual stenosis <30% after coronary stent implantation; ?restoration of TIMI anterograde flow of II or III).	Immediately after procedure
Secondary	Procedural success rate	Procedure success is defined as (1) Technical success; (2) Freedom from serious in-hospital procedural complications	Immediately after procedure
Secondary	Change in LVEF compared to baseline	LVEF is assessed at 30 days, 90 days after procedure, and compared to baseline.	30 days, 90 days after procedure
Secondary	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.	30 days, 90 days after procedure
Secondary	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).	Immediately after procedure