Phimume® Percutaneous Left Ventricular Assist System Study
ConditionCoronary Artery Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorShanghai NewMed Medical Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Percutaneous Ventricular Assist System
DevicePercutaneous Ventricular Assist System provides intraoperative circulatory support during high-risk PCI.
extracorporeal membrane oxygenation (ECMO)
DeviceECMO provides intraoperative circulatory support during high-risk PCI.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: percutaneous left ventricular assist systemExperimental treatment 1 intervention
Group B: extracorporeal membrane oxygenation (ECMO)Active comparator 1 intervention
Trial outcomes
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.
Time frame
30 days after procedureSecondary outcomes
1
Incidence of death
Rate of all-cause death during the trial.
Time frame
30 days, 90 days after procedure2
Incidence of myocardial infarction
Rate of patients with myocardial infarction during the trial.
Time frame
30 days, 90 days after procedure3
Incidence of stroke
Rate of patients with stroke during the trial.
Time frame
30 days, 90 days after procedure4
Incidence of target vessel revascularization
Rate of patients with target vessel revascularization during the trial.
Time frame
30 days, 90 days after procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai NewMed Medical Co., Ltd.
Lead sponsor
Shanghai Phigine Medical Technology Co., Ltd.
Collaborator
Source ClinicalTrials.gov
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