ELEVATE High-Risk PCI Pivotal Study

Обзор

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).

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• A composite of the incidence of major safety and effectiveness parameters. [Срок оценки: 30 days]

Вторичные конечные точки (4)

• Major Hemolysis during index hospitalization [Срок оценки: Perioperative/Periprocedural]
• Incidence of Bleeding Academic Research Consortium (BARC) Type 3 or Type 5 bleeding events related to the index percutaneous coronary intervention. [Срок оценки: Perioperative/Periprocedural]
• Length of hospital stay [Срок оценки: Perioperative/Periprocedural]
• Length of ICU/CCU stay [Срок оценки: Perioperative/Periprocedural]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 33 центра

• 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
• … и ещё 25 центров

Идентификаторы

NCT: NCT07001332 · DRD-0001723

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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