ELEVATE High-Risk PCI Pivotal Study

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 88 Years

Healthy Volunteers

Not accepted

Interventions

• Elevate — DEVICE
  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.
• Impella — DEVICE
  Subjects will receive an Impella prior to their high-risk percutaneous intervention.

Study Details

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).

Key Dates

First listed

Jun 3, 2025

Start date

Jul 25, 2025

Status verified

Jul 2026

Primary completion

Mar 16, 2027

Completion

Sep 16, 2027

Study Design

Enrollment

290 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Elevate
  Subjects receiving the Elevate System
• Active Comparator: Impella
  Subjects receiving the Impella System

Primary Outcome Measure

A composite of the incidence of major safety and effectiveness parameters. [ Time Frame: 30 days ]

Locations (33)

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