Health TrialsbyHealthPanel

ELEVATE High-Risk PCI Pivotal Study

ConditionHigh-Risk Percutaneous Coronary Intervention (High-risk PCI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-88
SponsorMagenta Medical Ltd.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Non-emergent, percutaneous coronary intervention is planned on at least one stenotic lesion of a native coronary artery or bypass graft (de novo or restenosis).

Baseline (uncorrected) hemoglobin >10.0 g/dl as long as an active source of blood loss has been reasonably excluded.

A heart team that includes an interventional cardiologist and cardiac surgeon has determined that HR- PCI is an appropriate therapeutic option.

Participant signed the informed consent.

Disqualifiers

Cardiogenic shock or acutely decompensated pre-existing chronic heart failure.

Prior stroke with any permanent, significant (mRS>2) neurological deficit, or stroke or TIA within 3 months prior to enrollment.

Any condition or scheduled surgery that will require discontinuation of the antiplatelet and/or anticoagulation therapy within 90 days of the index procedure.

Evidence of left ventricular thrombus.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

290 Participants
are divided into 2 treatment groups
Group A: ElevateExperimental treatment 1 intervention
Group B: ImpellaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

A composite of the incidence of major safety and effectiveness parameters.

A composite of the incidence of: 1. Major Adverse Cardiac and Cerebrovascular Events (MACCE): Death, Myocardial Infarction, Stroke or Transient Ischemic Attack, Unplanned Repeat Revascularization; 2. Major intra-procedural hemodynamic events on Mechanical Circulatory Support: Severe Hypotension, Cardio-Pulmonary Resuscitation or Cardioversion; 3. Major Mechanical Circulatory Support-related access site complications: Vascular Injury Requiring Intervention or Access Site Bleeding.

Time frame
30 days

Secondary outcomes

1

Major Hemolysis during index hospitalization

Incidence of Major Hemolysis

Time frame
Perioperative/Periprocedural
2

Incidence of Bleeding Academic Research Consortium (BARC) Type 3 or Type 5 bleeding events related to the index percutaneous coronary intervention.

The incidence of bleeding events related to the index percutaneous coronary intervention meeting the definition of Bleeding Academic Research Consortium (BARC) Type 3 or Type 5 bleeding.

Time frame
Perioperative/Periprocedural
3

Length of hospital stay

Length of hospital stay across all enrolled patients

Time frame
Perioperative/Periprocedural
4

Length of ICU/CCU stay

Length of ICU/CCU stay across all enrolled patients

Time frame
Perioperative/Periprocedural

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Magenta Medical Ltd.

Lead sponsor

Source ClinicalTrials.gov
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