The Duo venous stent system (Vesper Medical/Philips) showed a 98.7% freedom from major adverse events (MAEs) at 30 days and 90.2% primary patency at 12 months, results from the VIVID trial have revealed.
The data—which covered 162 subjects with nonthrombotic, acute thrombotic or chronic post-thrombotic clinically significant venous outflow obstruction—were presented during The VEINS 2023 (28–30 October, Las Vegas, USA) by Mahmood Razavi (St Joseph Heart & Vascular Center, Orange, USA), who highlighted how the trial provided “more clinical evidence in terms of durability and clinical improvement in these patients with venous outflow obstruction and venous stenting.”
The prospective, multicentre, single-arm, non-blinded clinical trial is designed to investigate the safety and efficacy of the Duo system as compared to pre-defined performance goals related to stenting of iliofemoral venous outflow obstructions.
The 98.7% freedom from MAE safety endpoint exceeded the peer-reviewed literature-driven performance goal of 89% with a highly significant p value, Razavi told The VEINS. The 12-month primary patency rate of 90.2% similarly exceeded its performance goal of 77%, he added.
“As expected, the best outcomes were in the non-thrombotic patients, followed by the acute thrombotic patients followed by the post-thrombotic patients,” Razavi explained.
He outlined significant sustained clinical improvement in term of CEAP (clinical, etiology, anatomy, pathophysiology) classification, Villalta score and venous clinical severity score (VCSS).
“The safety and efficacy of the stent system were established, and the endpoints were met,” Razavi concluded.