Phimume® Percutaneous Left Ventricular Assist System Study

Official title

The Safety and Efficacy of the Percutaneous Left Ventricular Assist System Versus ECMO for Intraoperative Circulatory Support During High-risk Percutaneous Coronary Intervention (PCI): a Prospective, Multi-center, Randomized Controlled Study

Overview

The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus extracorporeal membrane oxygenation (ECMO) 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.

Interventions

• Device Percutaneous Ventricular Assist System
  Percutaneous Ventricular Assist System provides intraoperative circulatory support during high-risk PCI.
• Device extracorporeal membrane oxygenation (ECMO)
  ECMO provides intraoperative circulatory support during high-risk PCI.

Primary outcome measures

• Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE) [Time frame: 30 days after procedure]

Secondary outcome measures (12)

• Incidence of death [Time frame: 30 days, 90 days after procedure]
• Incidence of myocardial infarction [Time frame: 30 days, 90 days after procedure]
• Incidence of stroke [Time frame: 30 days, 90 days after procedure]
• Incidence of target vessel revascularization [Time frame: 30 days, 90 days after procedure]
• Incidence of need for cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia [Time frame: 30 days, 90 days after procedure]
• Incidence of acute kidney injury Remove [Time frame: 30 days, 90 days after procedure]
• Incidence of cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion [Time frame: 30 days, 90 days after procedure]
• Incidence of increasing in aortic insufficiency by more than one grade [Time frame: 30 days, 90 days after procedure]
• Incidence of severe hypotension [Time frame: 30 days, 90 days after procedure]
• Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE) [Time frame: 90 days after procedure]
• Hemodynamic support success rate during PCI procedure [Time frame: During procedure]
• Technical success rate [Time frame: mmediately after procedure]

Eligibility criteria

Inclusion criteria

• 18 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.

Exclusion criteria

• 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);
• History of stroke or TIA within 1 month of enrolment;
• Allergy or intolerance to contrast media, anticoagulant and antiplatelet drugs (e.g., bivalirudin, low molecular heparin, aspirin, clopidogrel, Ticagrelor, etc.);
• Severe pulmonary artery hypertension (pulmonary artery systolic pressure >70 mmHg);
• Participation in clinical trials of other drugs or medical devices prior to enrollment that have not yet reached the primary outcome of research;
• Patient with poor compliance and could not complete the study as required determined by the investigator.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

China · 6 centers

• The Second Hospital of Jilin University — Jilin City
• West China Hospital, Sichuan University — Chengdu
• Henan Provincial Chest Hospital — Zhengzhou
• Renmin Hospital of Wuhan University — Wuhan
• The Second Xiangya Hospital of Central South University — Changsha
• General Hospital of Northern Theater Command — Shenyang

Identifiers

NCT: NCT06639321 · Phimume -2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗