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

NCT06099548 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-05-30

No results posted yet for this study

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.

Conditions

  • High-Risk Percutaneous Coronary Intervention

Interventions

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.

Sponsors & Collaborators

  • Magenta Medical Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
83 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-17
Primary Completion
2026-06-01
Completion
2026-06-01

Countries

  • Georgia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06099548 on ClinicalTrials.gov