David J. Dexter, (Sentara Healthcare, Norfolk, VA, USA), principal investigator of the CLOUT registry using the ClotTriever Mechanical Thrombectomy System (Inari Medical) for treatment of acute and chronic lower extremity DVT, presented the initial results for the first 50 patients in a late-breaking clinical trial session at VIVA 2019 (Vascular InterVentional Advances; 4–7 November, Las Vegas, NV, USA).
Dexter speaks to Venous News immediately after to outline why CLOUT is a unique registry that mimics a trial due to its robust data collection. He notes that lifting the lid on the data reveals that clot was removed in all patients, and over three-quarters of patients to date have met the study primary effectiveness endpoint of near-complete clot resolution (more than 75% clot clearance), making a strong case for the effectiveness of this device.
Importantly, these results were achieved entirely without the use of thrombolytic therapy and in a spectrum of patients who had acute, subacute and chronic clot. In terms of safety, there were no device-related major adverse events and no major bleeding events. The data also showed that there was significant improvement in the rate and severity of post-thrombotic syndrome (PTS), venous clinical severity score (VCSS) and Villalta score, as well as pain scores and quality-of-life indicators.
With ClotTriever, “we truly have a mechanical thrombectomy device that is dedicated to the iliac and femoral venous system” and it is changing the landscape by opening up new frontiers of care, says Dexter.
This video was sponsored by Inari Medical.