Phitys I™ Percutaneous Left Ventricular Assist System Study

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease
• Interventions: Device: Percutaneous Ventricular Assist System（Phigine Medical）; Device: intra-aortic balloon pump (IABP)

• Registration Number: NCT06357026
• Lead Sponsor: Shanghai NewMed Medical Co., Ltd.

Brief 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.

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 Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-01
• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-09
• Last Update Submitted: 2024-04-09
• Study First Posted: 2024-04-10
• Last Update Posted: 2024-04-10
• Primary Completion: 2025-05-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 344

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
percutaneous left ventricular assist system	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)	intra-aortic balloon pump (IABP)	Subjects with coronary artery disease receiving high-risk PCI will be supported by IABP during the procedure.

Primary Outcome Measures

Name	Time	Method
Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE)	30 days after procedure	MACCE defined as death, myocardial infarction, stroke, and target vessel revascularization.

Secondary Outcome Measures

Name	Time	Method
Incidence of acute kidney injury	30 days, 90 days after procedure	Rate of patients with acute kidney injury during the trial.
Incidence of cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion	30 days, 90 days after procedure	Rate of patients with cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion during the trial.
Incidence of myocardial infarction	30 days, 90 days after procedure	Rate of patients with myocardial infarction during the trial.
Incidence of death	30 days, 90 days after procedure	Rate of all-cause death during the trial.
Incidence of stroke	30 days, 90 days after procedure	Rate of patients with stroke during the trial.
Incidence of need for cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia	30 days, 90 days after procedure	Rate of patients with unplanned cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia during the trial.
Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE)	90 days after procedure	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.
Incidence of target vessel revascularization	30 days, 90 days after procedure	Rate of patients with target vessel revascularization during the trial.
Incidence of increasing in aortic insufficiency by more than one grade	30 days, 90 days after procedure	Rate of patients with increasing in aortic insufficiency by more than one grade during the trial.
Incidence of severe hypotension	30 days, 90 days after procedure	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.
Evaluation of Experimental device performance	Immediately after procedure	Performance evaluation includes the catheter pump and extracorporeal control device (For each assessment: 1-10 points；1=worst, 5=moderate, 10=best).
Incidence of failure to achieve angiographic success	30 days, 90 days after procedure	Rate of failure to achieve angiographic success during the trial. Angiographic success defined as residual stenosis \<30% after stent implantation.
Procedural success rate	Immediately after procedure	Procedure success is defined as (1) Technical success; (2) Freedom from serious in-hospital procedural complications
Improvement in cardiac function	30 days, 90 days after procedure	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.
Hemodynamic support success rate during PCI procedure	During 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).
Technical success rate	Immediately after procedure	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).
Change in LVEF compared to baseline	30 days, 90 days after procedure	LVEF is assessed at 30 days, 90 days after procedure, and compared to baseline.

Trial Locations

Locations (8)

The First Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

Henan Provincial Chest Hospital; 🇨🇳 Zhengzhou, Henan, China

Renmin Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China

General Hospital of Northern Theater Command; 🇨🇳 Shenyang, Liaoning, China

The Second Hospital of Jilin University; 🇨🇳 Jilin, Changchun, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China