ELEVATE High-Risk PCI Pivotal Study

Not Applicable

Not yet recruiting

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

• Registration Number: NCT07001332
• Lead Sponsor: Magenta Medical Ltd.

Brief Summary

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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-23
• Last Update Submitted: 2025-05-23
• Study First Posted: 2025-06-03
• Last Update Posted: 2025-06-03
• Study Start: 2025-07-16
• Primary Completion: 2027-03-16
• Study Completion: 2027-09-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

1. 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).
2. A heart team that includes an interventional cardiologist and cardiac surgeon has determined that HR- PCI is an appropriate therapeutic option.
3. Participant signed the informed consent.

Exclusion Criteria

1. Cardiogenic shock or acutely decompensated pre-existing chronic heart failure.
2. Prior stroke with any permanent, significant (mRS>2) neurological deficit, or stroke or TIA within 3 months prior to enrollment.
3. Any condition or scheduled surgery that will require discontinuation of the antiplatelet and/or anticoagulation therapy within 90 days of the index procedure.
4. Evidence of left ventricular thrombus.
5. Aortic valve stenosis/calcification (valve area ≤ 1.5 cm2).
6. ≥ Moderate aortic valve regurgitation (≥ 2+ on a 4-grade scale by transthoracic echocardiography).
7. Femoral access site incompatibility that precludes placement of either the Treatment or Control device.
8. Patient on dialysis.
9. Known or suspected coagulopathy OR abnormal coagulation parameters.
10. Known allergy, sensitivity or intolerance to nickel.
11. Infection of the proposed procedural access site; OR suspected systemic active infection, including any fever or known active COVID-19 infection.
12. Allergy, sensitivity or intolerance to heparin, or contrast media, including known heparin-induced thrombocytopenia (HIT).
13. Any non-cardiac condition with a life expectancy < 12 months.
14. 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).
15. Pregnancy or breast-feeding.
16. 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.
17. Subject belongs to a vulnerable population.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
A composite of the incidence of major safety and effectiveness parameters.	30 days	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.

Secondary Outcome Measures

Name	Time	Method
Major Hemolysis during index hospitalization	Perioperative/Periprocedural	Incidence of Major Hemolysis
Incidence of Bleeding Academic Research Consortium (BARC) Type 3 or Type 5 bleeding events related to the index percutaneous coronary intervention.	Perioperative/Periprocedural	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.
Length of hospital stay	Perioperative/Periprocedural	Length of hospital stay across all enrolled patients
Length of ICU/CCU stay	Perioperative/Periprocedural	Length of ICU/CCU stay across all enrolled patients