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ELEVATE High-Risk PCI Pivotal Study

NCT07001332 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 290

Last updated 2026-04-28

No results posted yet for this study

Summary

The ELEVATE III Pivotal Study is a prospective, multi-center, open-label, interventional, randomized, controlled study with an active control group. The study is intended to assess the safety and efficacy of the Elevate™ percutaneous Left Ventricular Assist Device System in patients referred to high-risk percutaneous coronary interventions (HR-PCI).

Conditions

  • High-Risk Percutaneous Coronary Intervention (High-risk PCI)

Interventions

DEVICE

Elevate

The Elevate System is a catheter- mounted, self-expanding and retrievable, continuous-flow pump, designed to unload the left ventricle by actively transporting blood from the left ventricle into the ascending aorta, thus augmenting cardiac output and maintaining systemic arterial pressure during complex/high-risk coronary interventions. Subjects will receive an Elevate prior to their high-risk percutaneous intervention.

DEVICE

Impella

Subjects will receive an Impella prior to their high-risk percutaneous intervention.

Sponsors & Collaborators

  • Magenta Medical Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
88 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-25
Primary Completion
2027-03-16
Completion
2027-09-16
FDA Device
Yes

Countries

  • United States

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 NCT07001332 on ClinicalTrials.gov