Clinical trial NCT06357026: Phitys I™ Percutaneous Left Ventricular Assist System Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Shanghai NewMed Medical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shanghai Phigine Medical Technology Co., Ltd.
First posted: 2024-04-10
Enrollment: 344
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE)
timeFrame: 30 days after procedure
Secondary outcomes:
measure: Incidence of death
timeFrame: 30 days, 90 days after procedure
measure: Incidence of myocardial infarction
timeFrame: 30 days, 90 days after procedure
measure: Incidence of stroke
timeFrame: 30 days, 90 days after procedure
measure: Incidence of target vessel revascularization
timeFrame: 30 days, 90 days after procedure
measure: Incidence of need for cardiac operation or thoracic or abdominal vascular operation or vascular operation for limb ischemia
timeFrame: 30 days, 90 days after procedure
measure: Incidence of acute kidney injury
timeFrame: 30 days, 90 days after procedure
measure: Incidence of cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion
timeFrame: 30 days, 90 days after procedure
measure: Incidence of increasing in aortic insufficiency by more than one grade
timeFrame: 30 days, 90 days after procedure
measure: Incidence of severe hypotension
timeFrame: 30 days, 90 days after procedure
measure: Incidence of failure to achieve angiographic success
timeFrame: 30 days, 90 days after procedure
measure: Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE)
timeFrame: 90 days after procedure
measure: Hemodynamic support success rate during PCI procedure
timeFrame: During procedure
measure: Technical success rate
timeFrame: Immediately after procedure
measure: Procedural success rate
timeFrame: Immediately after procedure
measure: Change in LVEF compared to baseline
timeFrame: 30 days, 90 days after procedure
measure: Improvement in cardiac function
timeFrame: 30 days, 90 days after procedure
measure: Evaluation of Experimental device performance
timeFrame: Immediately after procedure
Other outcomes:
Locations:
city: Jilin
country: China
facility: The Second Hospital of Jilin University
state: Changchun
city: Harbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Provincial Chest Hospital
state: Henan
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Shenyang
country: China
facility: General Hospital of Northern Theater Command
state: Liaoning
city: Shanghai
country: China
facility: Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: The General Hospital of Northern Theater Command
name: Yaling Han
role: PRINCIPAL_INVESTIGATOR
References: