Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-02 @ 2:50 AM
Study NCT ID:
NCT06132568
Status:
COMPLETED
Last Update Posted:
2025-06-22
First Post:
2023-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VITALYST Early Feasibility Study in High-Risk PCI Patients (VITALYST EFS)
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
VITALYST EFS: VITALYST Temporary Percutaneous Transvalvular Circulatory Support System Early Feasibility Study
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VITALYST EFS
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).
Detailed Description:
The VITALYST EFS is a prospective, open-label, single-arm, multicenter feasibility study of the VITALYST System.
The VITALYST System will be used to provide temporary circulatory support in patients undergoing non-emergent high risk percutaneous interventions (HR-PCI).
The VITALYST System will be used to provide temporary circulatory support in patients undergoing non-emergent high risk percutaneous interventions (HR-PCI).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: