Magenta Elevate™ First-in-Human Clinical Study in High-Risk PCI Patients — ELEVATE I  

High-Risk Percutaneous Coronary Intervention Clinical Trial

Official title: First-in-Human (FIH) Clinical Investigation Protocol of the Magenta Elevate™ Percutaneous Left Ventricular Assist Device (pLVAD) System in Patients Undergoing Non-emergent, High-risk Percutaneous Coronary Interventions (ELEVATE I)

Status Active, not recruiting

Clinical Trial Summary

The Elevate™ First-In-Human (FIH) study is designed to evaluate the initial safety and device functionality of the Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary interventions.

Clinical Trial Description

The Elevate™ System FIH study is planned as a prospective, single-arm, interventional study of up to 20 patients.

The Magenta Elevate™ is a temporary (≤ 6 hours) ventricular support device indicated for use during high-risk percutaneous coronary interventions (HR-PCI) performed electively or urgently in hemodynamically stable patients, with severe coronary artery disease.

The Magenta Elevate™ Pump is a catheter-mounted, self-expanding and retrievable pump, designed to unload the left ventricle by actively transporting blood from the left ventricle into the ascending aorta. ;

Related Conditions & MeSH terms

• High-Risk Percutaneous Coronary Intervention

• NCT number: NCT06099548
• Study type: Interventional
• Source: Magenta Medical Ltd.
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 17, 2020
• Completion date: March 2024