CorVad Percutaneous Ventricular Assist System Study

Status Recruiting

Clinical Trial Summary

This study aims to evaluate the safety and effectiveness of the CorVad Percutaneous Ventricular Assist System for short-term ventricular support during high-risk percutaneous coronary intervention (HRPCI) in non-emergent, hemodynamically stable coronary artery disease patients via a prospective, multicenter, single-arm clinical trial.

Clinical Trial Description

This prospective, multicentre, single-arm clinical trial of the CorVad Percutaneous Ventricular Assist System is designed to measure the incidence of major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days after PCI and is planned to enrol 120 subjects. The target population of subjects are patients with coronary artery disease who need high-risk PCI treatment, and sign an informed consent form (ICF) approved by the Ethics Committee (EC). Subjects who meet the enrolment criteria as judged by the investigator will apply the trial product according to the requirements and will be followed up to 30 days after the procedure. ;

Study Design

Related Conditions & MeSH terms

Coronary Artery Disease

Clinical Trial Details

NCT number	NCT06198998
Study type	Interventional
Source	Shenzhen Core Medical Technology CO.,LTD.
Contact	Xiaoli Shi
Phone	+86 13418601356
Email	shixiaoli@coretechmed.com
Status	Recruiting
Phase	N/A
Start date	October 19, 2023
Completion date	October 18, 2024

View Details

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