ELEVATE High-Risk PCI Pivotal Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Elevate, Impella.
- Who it may be relevant to
- Registry conditions: High-Risk Percutaneous Coronary Intervention (High-risk PCI). Basic parameters: 18 years — 88 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Detailed description
The Elevate™ percutaneous Left Ventricular Assist Device System 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. Use of the Elevate™ System in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions.
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.
Primary outcome measures
- A composite of the incidence of major safety and effectiveness parameters. [Time frame: 30 days]
Secondary outcome measures (4)
- Major Hemolysis during index hospitalization [Time frame: Perioperative/Periprocedural]
- Incidence of Bleeding Academic Research Consortium (BARC) Type 3 or Type 5 bleeding events related to the index percutaneous coronary intervention. [Time frame: Perioperative/Periprocedural]
- Length of hospital stay [Time frame: Perioperative/Periprocedural]
- Length of ICU/CCU stay [Time frame: Perioperative/Periprocedural]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 33 centers
- Banner-University Medical Center — Phoenix
- HonorHealth Scottsdale Shea Medical Center/HonorHealth Deer Valley Medical Center — Scottsdale
- UC San Diego Medical Center — La Jolla
- University of California at San Francisco Medical Center/Zuckerberg San Francisco General — San Francisco
- Tampa General/USF — Tampa
- Emory University Hospital / Emory University Hospital Midtown/ Emory Saint Joseph's Hospit — Atlanta
- Wellstar Health System — Marietta
- University of Illinois at Chicago — Chicago
- … and 25 more centers
Identifiers
NCT: NCT07001332 · DRD-0001723