VITALYST System for Heart Disease
(VITALYST EFS Trial)
Trial Summary
What is the purpose of this trial?
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).
Eligibility Criteria
The VITALYST EFS is for adults aged 18 to less than 90 who need a non-emergency procedure (HR-PCI) for heart vessel blockages and have reduced heart pump function. They must agree to the study's terms, be evaluated by a heart team including a surgeon, and not be in an emergency situation.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
The VITALYST System is used to provide temporary circulatory support during high-risk percutaneous coronary interventions
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- VITALYST System
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Who Is Running the Clinical Trial?
Boston Scientific Corporation
Lead Sponsor
Michael F. Mahoney
Boston Scientific Corporation
Chief Executive Officer since 2016
MBA from Wake Forest University, BBA in Finance from the University of Iowa
Kenneth Stein
Boston Scientific Corporation
Chief Medical Officer since 2020
MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology