NCT06099548

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Magenta Medical Ltd. · Industry
• Sex: All
• Age: 40 Years – 83 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• High-Risk Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DEVICE	The Elevate™ System	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.

Timeline

• Start date: 2020-12-17
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-10-25
• Last updated: 2025-05-30

Locations

2 sites across 1 country: Georgia