VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)

NCT06132568 | Completed DMC FDA Device

• 1 other identifier: S2496
• Study Type: interventional
• Target: 15
• Locations: 2 countries
• Sites: 5

Brief Summary

The VITALYST Early Feasibility study (EFS) is designed to evaluate the feasibility and safety of the VITALYST System in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).

Conditions

High-risk Percutaneous Coronary Intervention; Heart Disease, Coronary

Outcome Measures

Primary Outcomes (1)

• Clinical Success

  The primary endpoint consists of the composite endpoint of Clinical Success \[measured through 72 hours or hospital discharge (whichever comes first)\], which is defined as follows. * Technical Success: Successful delivery of the device to the correct anatomical position; and Successful operation and removal of the VITALYST circulatory support system * Absence of termination of revascularization procedure due to hemodynamic concern, or escalation to ECMO or other more intensive mechanical circulatory support device, or the use of vasopressors or inotropes * No conversion to open heart surgery * No mortality

  Measured through 72 hours or hospital discharge (whichever comes first) after the intervention/procedure

Study Arms (1)

High Risk PCI Patients

EXPERIMENTAL

Patients undergoing non-emergent, high-risk percutaneous coronary interventions

Device: VITALYST System

Interventions

VITALYST System DEVICE

The VITALYST System is a temporary ventricular support device indicated for use during high-risk percutaneous coronary interventions (HR-PCI) performed electively in hemodynamically stable subjects with severe coronary artery disease.

Also known as: Percutaneous Mechanical Circulatory Support

High Risk PCI Patients

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject provides signed informed consent.
• Subject is ≥ 18 years and \< 90 years of age.
• Subject is indicated for NON-emergent PCI of at least one de novo or restenotic lesion in a native coronary vessel or coronary artery bypass graft (CABG) and has left ventricular ejection fraction (LVEF) ≤ 50% with the following: Unprotected left main or Last remaining vessel or Three vessel disease (at least one ≥ 50% diameter stenosis based on center's visual assessment in all three major epicardial territories)
• Heart team, which must include a cardiac surgeon, agrees that HR-PCI is appropriate.

You may not qualify if:

• Subject has had STEMI within 72 hours with persistent elevation of cardiac enzymes.
• Subject has had pre-procedure cardiac arrest requiring CPR within 24 hours of enrollment.
• Subject has systolic blood pressure \< 90 mmHg with evidence of end organ hypoperfusion (e.g., cool extremities or urine \< 30 mL/hour).
• Subject has had need for inotropes/vasopressors or mechanical circulatory support (including intra-aortic balloon pump) in the previous 24 hours to maintain a systolic blood pressure ≥ 90 mmHg.
• Subject has left ventricular mural thrombus.
• Subject has a prosthetic aortic valve.
• Subject has pericarditis or constrictive heart disease (constrictive pericarditis or restrictive cardiomyopathy).
• Subject has moderate or greater aortic valve stenosis or moderate or greater aortic valve insufficiency (by echocardiographic assessment, graded as \> 2+).
• Subject has abnormalities of the aorta that preclude safe delivery of the device, including severe calcification, tortuosity, aneurysm, or prior surgery.
• Subject has PVD preventing passage of the device (e.g., calcification, small caliber) or tortuosity that would preclude safe placement of the introducer sheath as per the IFU.
• Subject is not on dialysis and has creatinine \> 4 mg/dL.
• Subject has a history of liver dysfunction (Childs Class C) with elevation of liver enzymes and bilirubin \> 3× ULN or INR ≥ 2.
• Subject has had a recent (within 30 days) stroke or TIA.
• Subject has known hypersensitivity to intravenous contrast agents that cannot be adequately pre-medicated or has known hypersensitivity to heparin, aspirin, ADP receptor inhibitors or nitinol.
• Subject has current or a history of heparin induced thrombocytopenia.

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (5)

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, 10032, United States

Location

Skane University Hospital

Lund, 222 42, Sweden

Location

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 15, 2023
• Study Start: May 9, 2024
• Primary Completion: October 24, 2024
• Study Completion: January 17, 2025
• Last Updated: June 22, 2025

Record last verified: 2025-06

Locations

SE (1); US (4)