The multi-centre, single arm and open-label clinical trial will enroll up to 265 patients and the first patient has been recruited at Atlantic Health System’s Morristown Medical Center in New Jersey
Saranas has commenced Early Bird bleed monitoring system trial. (Credit: Silas Camargo Silão from Pixabay)
Saranas has started a clinical trial of the Early Bird bleed monitoring system to evaluate the utility of early detection of bleeding in patients undergoing mechanical circulatory support.
The study will assess the impact of the system on reducing bleeding complications in patients undergoing high-risk percutaneous coronary intervention (PCI) with mechanical circulatory support (MCS) and surveillance.
The first patient in the SAFE-MCS trial has been recruited at Atlantic Health System’s Morristown Medical Center in New Jersey.
Saranas intends to recruit up to 265 patients in the multi-centre, single arm and open-label clinical trial in the US.
Incidence of access-site related BARC (Bleeding Academic Research Consortium) type III or V bleeding is the primary endpoint of the study.
The company will enroll patients undergoing complex high-risk PCI with MCS through Impella and transfemoral arterial approach as study participants in the trial.
To monitor bleeding events after MCS removal, the Early Bird bleed monitoring system will be used in the ipsilateral femoral vein.
For evaluating cost savings associated with the Early Bird in the SAFE-MCS trial, the company is collaborating with the Cardiovascular Research Foundation (CRF) Clinical Trials Centre.
Saranas president and CEO James Reinstein said: “SAFE-MCS is the first prospective trial focused exclusively on the impact of integrating bleed monitoring in large-bore access for high-risk protected PCI patients.
“Saranas is committed to building objective evidence to support the clinical utility of the Early Bird device. We are pleased to support the SAFE-MCS study, and we wish to thank the investigators for their efforts to commence the trial.”
The Early Bird bleed monitoring system consists of a bleed detection array with integrated electrodes in a fully functional vascular access sheath.
Saranas has designed the system for the measurement of changes in bioimpedance to identify and monitor bleeding from vessel injury during endovascular procedures such as a transcatheter aortic valve replacement (TAVR), hemodynamic support device placement, or other complex endovascular interventions.
Onset and progression of bleeding events will be informed to the clinician by the visual and audible indicators of the Early Bird system.