Phitys I™ Percutaneous Left Ventricular Assist System Study

NCT06357026 | Not Yet Recruiting

• 1 other identifier: Phitys I -2024
• Study Type: interventional
• Target: 344
• Locations: 1 country
• Sites: 8

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Incidence of death

  30 days, 90 days after procedure

• Incidence of myocardial infarction

  30 days, 90 days after procedure

• Incidence of stroke

  30 days, 90 days after procedure

• Incidence of target vessel revascularization

  30 days, 90 days after procedure

• Incidence of need for cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia

  30 days, 90 days after procedure

Study Arms (2)

percutaneous left ventricular assist system

EXPERIMENTAL

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）

intra-aortic balloon pump (IABP)

ACTIVE COMPARATOR

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

Device: intra-aortic balloon pump (IABP)

Interventions

Percutaneous Ventricular Assist System（Phigine Medical） DEVICE

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

percutaneous left ventricular assist system

intra-aortic balloon pump (IABP) DEVICE

IABP provides intraoperative circulatory support during high-risk PCI.

intra-aortic balloon pump (IABP)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Shanghai NewMed Medical Co., Ltd.: lead
• Shanghai Phigine Medical Technology Co., Ltd.: collaborator

Study Sites (8)

The Second Hospital of Jilin University

Jilin, Changchun, China

Location

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

Henan Provincial Chest Hospital

Zhengzhou, Henan, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Location

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Intra-Aortic Balloon Pumping

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Counterpulsation; Assisted Circulation; Surgical Procedures, Operative

Study Officials

• Yaling Han

  The General Hospital of Northern Theater Command

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yang Xu

CONTACT

+86 021-20788668; xu_yang@newmed.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 10, 2024
• Study Start: April 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: April 1, 2026
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

CN (8)