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

Shanghai NewMed Medical Co., Ltd.8 sites in 1 country344 target enrollmentApril 1, 2024

ConditionsCoronary Artery Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Shanghai NewMed Medical Co., Ltd.
Enrollment: 344
Locations: 8
Primary Endpoint: Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE)
Status: Not Yet Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 1, 2024

End Date

April 1, 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai NewMed Medical Co., Ltd.

Responsible Party

Sponsor

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;

Outcomes

Primary Outcomes

Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE)

Time Frame: 30 days after procedure

MACCE defined as death, myocardial infarction, stroke, and target vessel revascularization.

Secondary Outcomes

Incidence of acute kidney injury(30 days, 90 days after procedure)
Incidence of cardiopulmonary resuscitation or ventricular arrhythmia requiring cardioversion(30 days, 90 days after procedure)
Incidence of myocardial infarction(30 days, 90 days after procedure)
Incidence of death(30 days, 90 days after procedure)
Incidence of stroke(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)
Incidence of freedom from major adverse cardiovascular and cerebrovascular events (MACCE)(90 days after procedure)
Incidence of target vessel revascularization(30 days, 90 days after procedure)
Incidence of increasing in aortic insufficiency by more than one grade(30 days, 90 days after procedure)
Incidence of severe hypotension(30 days, 90 days after procedure)
Evaluation of Experimental device performance(Immediately after procedure)
Incidence of failure to achieve angiographic success(30 days, 90 days after procedure)
Procedural success rate(Immediately after procedure)
Hemodynamic support success rate during PCI procedure(During procedure)
Technical success rate(Immediately after procedure)
Change in LVEF compared to baseline(30 days, 90 days after procedure)
Improvement in cardiac function(30 days, 90 days after procedure)