143 - DEEPER OUS Trial Update: the Bare Temporary Spur Stent System followed by a Paclitaxel-coated Balloon
Purpose: To evaluate the safety and efficacy of the Bare Temporary Spur Stent System in conjunction with a commercially available, paclitaxel coated balloon for the treatment of infrapopliteal arterial disease.
Material and Methods: The DEEPER OUS trial is a prospective, non-randomized, multicenter, single arm conducted in Europe and New Zealand with follow up at 1, 3, 6, 12 months, then annually to 5 years. Enrollment is complete with 107 subjects been enrolled as of April, 2022. An interim analysis of at least the first 40 subjects with evaluable data and no major protocol violations has been conducted, meeting the criteria for study success as compared to a pre-defined performance goal. The study design also includes a vessel recoil sub-study of 38 subjects in whom vessel recoil was measured at 15 minutes post treatment with the study device. The primary safety endpoint is freedom from device and procedure-related death through 30 days post-procedure; the primary efficacy endpoint is patency of treated lesion sites by duplex ultrasound at 6 months. Secondary safety endpoints include freedom from target limb MALE and all-cause POD at 30 days, and freedom from major amputation of the target limb at 12 months. Secondary efficacy endpoints include freedom from clinically driven TLR (CD-TLR) through 6 months post procedure, improvement in Rutherford class score at 3, 6, and 12, months, and wound healing for subjects with Rutherford class 5 at 6 and 12 months.
Results: 37/46 (80.4%) of subjects met the primary efficacy endpoint of patency by DUS at 6 months. 100% (46/46) of subject met the primary endpoint of freedom from device and procedure-related death through 30 days. Freedom from CD-TLR was 41/46 (89.1%). There was a 34.8% reduction in wound size at 6 months, and average Rutherford class score decreased by 3 classes by 6 months. Freedom from target limb MALE and all-cause POD at 30 days was 100% (46/46), and freedom from major amputation of the target limb at 12 months was 46/46. Analysis of the vessel recoil substudy is ongoing and will be presented at the ISET conference.
Conclusions: Preliminary data from the DEEPER OUS clinical trial suggest that the Bare Temporary Spur Stent System in combination with a commercially available paclitaxel coated balloon is effective and safe for the treatment of infrapopliteal arterial disease. Further data is needed to confirm long term safety and efficacy.