Today at the 2019 Vascular Interventional Advances conference (VIVA; 4–7 November, Las Vegas, USA), Thomas Zeller (Bad Krozingen, Germany) gave an update on the DEEPER OUS trial. He concluded that the Temporary Spur stent system (Reflow Medical) appears to be a feasible and safe method for the treatment of disease in the infrapopliteal arteries.
This trial is a prospective, multicentere nonrandomised, single-arm study. Trial enrolment began in July 2019 and is presently ongoing, with anticipated completion in 2020. The study will consist of 100 patients in New Zealand, Germany, and Switzerland.
The purpose of the DEEPER OUS study is to evaluate the safety and efficacy of a novel device, the Temporary Spur stent system in conjunction with a commercially available drug-coated balloon. An angiographic substudy examining recoil will be conducted on the first 10 patients from each site.
Examination of patency rates and long-term safety data is ongoing in the DEEPER OUS trial.