BMC is Sponsor and CRO for the Global Clinical Study: Genetic Loci and the Burden of Atherosclerotic Lesions
- Genomic and biomarker based discovery of pathways of cardiovascular disease that will lead to better treatments
- Pivotal landmark cardiovascular disease study using advanced cardiovascular imaging for phenotyping, a panomic approach to identify underlying genomic, proteomic, metabolomic, and lipidomic underpinnings, analyzed by systems
- 10,000 patients worldwide
- Six Australian sites (QLD, NSW, VIC)
BMC was Sponsor and monitored the Novate Inferior Vena Cava Filter Clinical Study
- Novate’s Sentry IVC filter is a novel bioconvertible vena cava filter, which automatically converts from a filtering (conical) to a non-filtering (stent) configuration after a minimum of 60 days from implantation, and therefore does not require retrieval. It is intended to offer temporary protection from a pulmonary embolism for a period of time and then become incorporated into the vena cava wall.
- First-in-man study provided evidence confirming that the Sentry filter can be successfully deployed as intended without complications, can provide protection from pulmonary embolism for 60 days, and can reduce known early- and late-stage complications associated with filters.
- Enrolled 14 patients of whom 12 remained in the study through a 12-month follow-up. The operators achieved technical success in all patients (defined as deployment at intended site without tilting, migration, fracture, thrombosis, stenosis, damage, or significant complications at the access vein site).
- The researchers achieved clinical success in all 12 patients (as defined as the absence of pulmonary embolism and inferior vena caval occlusion during the indicated protection period of 60 days). There was no pulmonary embolism or occlusion at any time point throughout the 12-month follow-up.
What we did
- Sponsorship and monitoring
- Development of the clinical investigational plan and protocol
- Preparation and submission of Ethics (IRB) documents
- Identification of trial sites and building relationships with Key Opinion Leaders and Principal Investigators
- Site invitation visits
- Trial management
- Monitoring and reporting of the trial data collection