Phitys I™ Percutaneous Left Ventricular Assist System Study

NCT ID: NCT06357026

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 344 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-04-01

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Percutaneous Ventricular Assist System（Phigine Medical）

Intervention Type: DEVICE

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

intra-aortic balloon pump (IABP)

Subjects with coronary artery disease receiving high-risk PCI will be supported by IABP during the procedure.

Group Type: ACTIVE_COMPARATOR

intra-aortic balloon pump (IABP)

Intervention Type: DEVICE

IABP provides intraoperative circulatory support during high-risk PCI.

Interventions

Percutaneous Ventricular Assist System（Phigine Medical）

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

Intervention Type: DEVICE

intra-aortic balloon pump (IABP)

IABP provides intraoperative circulatory support during high-risk PCI.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Phigine Medical Technology Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Shanghai NewMed Medical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yaling Han

Role: PRINCIPAL_INVESTIGATOR

The General Hospital of Northern Theater Command

Locations

The Second Hospital of Jilin University

Jilin, Changchun, China

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

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Countries

China

Central Contacts

Yang Xu

Role: CONTACT

xu_yang@newmed.cn

+86 021-20788668

Facility Contacts

Bin Liu

Role: primary

Yue Li

Role: primary

Yiqiang Yuan

Role: primary

Hong Jiang

Role: primary

Shenghua Zhou

Role: primary

Yaling Han

Role: primary

Li Zhang

Role: primary

Mao Chen

Role: primary

Other Identifiers

Phitys I -2024

Identifier Type: -

Identifier Source: org_study_id