RECRUITING

ELEVATE High-Risk PCI Pivotal Study

Conditions

High-Risk Percutaneous Coronary Intervention (High-risk PCI)

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Study Overview

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Description

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).

Official Title

ELEVATE High-Risk PCI Pivotal Study

Quick Facts

Study Start:2025-07-25

Study Completion:2027-09-16

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07001332

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 88 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Locations (Sites)

North Shore University Hospital

Manhasset, New York, 11030

United States

Mount Sinai

New York, New York, 10029

United States

Weill Cornell Medical Center

New York, New York, 10065

United States

Collaborators and Investigators

Sponsor: Magenta Medical Ltd.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07-25

Study Completion Date2027-09-16

Study Record Updates

Study Start Date2025-07-25

Study Completion Date2027-09-16

Terms related to this study

Additional Relevant MeSH Terms

High-Risk Percutaneous Coronary Intervention (High-risk PCI)