ELEVATE High-Risk PCI Pivotal Study | NCT07001332

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Elevate	Experimental	Subjects receiving the Elevate System	Device: Elevate
Impella	Active Comparator	Subjects receiving the Impella System	Device: Impella

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	30 days

Secondary Outcomes

Measure	Description	Time Frame
Major Hemolysis during index hospitalization	Incidence of Major Hemolysis	Perioperative/Periprocedural
Incidence of Bleeding Academic Research Consortium (BARC) Type 3 or Type 5 bleeding events related to the index percutaneous coronary intervention.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).
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.

Exclusion Criteria:

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.
Aortic valve stenosis/calcification (valve area ≤ 1.5 cm2).
≥ Moderate aortic valve regurgitation (≥ 2+ on a 4-grade scale by transthoracic echocardiography).
Femoral access site incompatibility that precludes placement of either the Treatment or Control device.
Patient on dialysis.
Known or suspected coagulopathy OR abnormal coagulation parameters.
Known allergy, sensitivity or intolerance to nickel.
Infection of the proposed procedural access site; OR suspected systemic active infection, including any fever or known active COVID-19 infection.
Allergy, sensitivity or intolerance to heparin, or contrast media, including known heparin-induced thrombocytopenia (HIT).
Any non-cardiac condition with a life expectancy < 12 months.
Subject participation in another investigational drug or device trial (with the exception of post-market registries and observational studies, subject to Sponsor review and approval).
Pregnancy or breast-feeding.
Subject has other medical, social, or psychological problems that, in the opinion of the Investigator, compromise the participant's ability to provide written informed consent and/or to comply with study procedures.
Subject belongs to a vulnerable population.