NCT05077657

Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 203 (actual)
• Sponsor: Saranas, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to establish the safety of complex high-risk Percutaneous Coronary Intervention (PCI) using Mechanical Circulatory Support (MCS) and surveillance with the Saranas Early Bird Bleed Monitoring System (EBBMS).

Detailed description

To demonstrate that patients undergoing complex high-risk PCI using MCS and surveillance with the Saranas Early Bird Bleed Monitoring System will have relative incidence rate reduction of access site related BARC type III or V bleeding. An optimal outcome will show a a reduction in access-site related bleeding rate when using MCS with the Saranas EBBMS in high-risk PCI patients compared to historical incidence rate.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Early Bird® Bleed Monitoring System	The Early Bird Bleed Monitoring System is used in endovascular procedures to monitor and detect internal bleeding complications in real-time.
DEVICE	Impella®	Impella is an FDA-approved percutaneous heart pump indicated for patients with severe coronary artery disease requiring high-risk PCI.

Timeline

• Start date: 2021-11-29
• Primary completion: 2023-12-19
• Completion: 2023-12-19
• First posted: 2021-10-14
• Last updated: 2024-02-16

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated device study