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
Qualifiers
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
Treatments tested in this trial
- Percutaneous Ventricular Assist System
- extracorporeal membrane oxygenation (ECMO)
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Shanghai NewMed Medical Co., Ltd.
Lead sponsor
Shanghai Phigine Medical Technology Co., Ltd.
Collaborator
Source ClinicalTrials.gov