NCT06132568

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

VITALYST EFS: VITALYST Temporary Percutaneous Transvalvular Circulatory Support System Early Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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).

Conditions

• High-risk Percutaneous Coronary Intervention
• Heart Disease, Coronary

Interventions

Type	Name	Description
DEVICE	VITALYST System	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.

Timeline

• Start date: 2024-05-09
• Primary completion: 2024-10-24
• Completion: 2025-01-17
• First posted: 2023-11-15
• Last updated: 2025-06-22

Locations

5 sites across 2 countries: United States, Sweden

Regulatory

• FDA-regulated device study