Phitys I™ Percutaneous Left Ventricular Assist System Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Percutaneous Ventricular Assist System（Phigine Medical）; Device: intra-aortic balloon pump (IABP)

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 Type: Interventional
• Enrollment (Estimated): 344
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yang Xu; Phone Number: +86 021-20788668; Email: xu_yang@newmed.cn

Study Locations

• China
  • Changchun
    • Jilin, Changchun, China
      • The Second Hospital of Jilin University
      • Contact: Bin Liu
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • The First Affiliated Hospital of Harbin Medical University
      • Contact: Yue Li
  • Henan
    • Zhengzhou, Henan, China
      • Henan Provincial Chest Hospital
      • Contact: Yiqiang Yuan
  • Hubei
    • Wuhan, Hubei, China
      • Renmin Hospital of Wuhan University
      • Contact: Hong Jiang
  • Hunan
    • Changsha, Hunan, China
      • The Second Xiangya Hospital Of Central South University
      • Contact: Shenghua Zhou
  • Liaoning
    • Shenyang, Liaoning, China
      • General Hospital of Northern Theater Command
      • Contact: Yaling Han
  • Shanghai
    • Shanghai, Shanghai, China
      • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Contact: Li Zhang
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital, Sichuan University
      • Contact: Mao Chen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: percutaneous left ventricular assist system; Subjects with coronary artery disease receiving high-risk PCI will be supported by Percutaneous Ventricular Assist System during the procedure.	Device: Percutaneous Ventricular Assist System（Phigine Medical）; Percutaneous Ventricular Assist System or IABP provides intraoperative circulatory support during high-risk PCI.
Active Comparator: intra-aortic balloon pump (IABP); Subjects with coronary artery disease receiving high-risk PCI will be supported by IABP during the procedure.	Device: intra-aortic balloon pump (IABP); IABP provides intraoperative circulatory support during high-risk PCI.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of death	Rate of all-cause death during the trial.	30 days, 90 days after procedure
Incidence of myocardial infarction	Rate of patients with myocardial infarction during the trial.	30 days, 90 days after procedure
Incidence of stroke	Rate of patients with stroke during the trial.	30 days, 90 days after procedure
Incidence of target vessel revascularization	Rate of patients with target vessel revascularization during the trial.	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.	30 days, 90 days after procedure
Incidence of acute kidney injury	Rate of patients with acute kidney injury during the trial.	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.	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.	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.	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.	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.	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).	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).	Immediately after procedure
Procedural success rate	Procedure success is defined as (1) Technical success; (2) Freedom from serious in-hospital procedural complications	Immediately after procedure
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
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
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

Collaborators and Investigators

• Sponsor: Shanghai NewMed Medical Co., Ltd.
• Collaborators: Shanghai Phigine Medical Technology Co., Ltd.
• Investigators: Principal Investigator: Yaling Han, The General Hospital of Northern Theater Command

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 10, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: Phitys I -2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No