DEEPER LIMUS Trial Update: the Bare Temporary Spur Stent System Followed by a Sirolimus-Coated Balloon

M. Brodmann

Purpose: To evaluate the safety and efficacy of the Bare Temporary Spur Stent System in conjunction with a commercially available sirolimus-coated balloon for the treatment of infrapopliteal arterial disease.

Materials and Methods: The DEEPER LIMUS pilot study is a prospective, nonrandomized, single-center, single-arm trial with follow-up at 1, 3, 6, and 12 months. Twenty-six participants have been enrolled as of October 2022; enrollment in the trial is ongoing. The primary endpoint is a composite of all-cause mortality, major amputation, and clinically driven target lesion revascularization (CD-TLR) at 6 months. Secondary endpoints include late lumen loss at 6 months, primary patency by angiography at 6 months, improvement in clinical outcomes, freedom from major adverse limb event (MALE) and all-cause perioperative death at 30 days, and freedom from MALE at 6 and 12 months after the procedure.

Results: As of October 2022, 22 participants have reached 6 months of follow-up and have been evaluated for the primary safety endpoint. One participant underwent CD-TLR at the 6 month timepoint, 1 subject underwent a major amputation because of infection at 30 days, and 1 participant died of COVID-19 during the 3-month follow-up timepoint (3 of 22; (13.6%)). All subjects have met the secondary safety endpoint of freedom from MALE and perioperative death, and 21 of 22 (95%) and 15 of 16 (93.8%) of participants have met the secondary safety endpoint of freedom from MALE at 6 and 12 months, respectively. Patency by duplex ultrasonography (USG) has been analyzed in the first 22 participants with diagnostic USG according to the USG core lab; 19 of 22 (86%) participants had patency at 6 months. Patency by angiography has been performed on 18 participants, with 15 of 18 (83.3%) participants found patent at 6 months according to the angiographic core lab. Rutherford class score has improved by an average of more than two classes from baseline to 6 months, and Wound Ischemia foot Infection risk scores for participants with Rutherford class 5 have shown improvement in risk score of approximately 50%.

Conclusions: Preliminary data from the DEEPER LIMUS clinical trial suggest that infrapopliteal arterial disease can be safely and effectively treated with the Bare Temporary Spur Stent System in combination with a commercially available sirolimus-coated balloon. Further data are needed to confirm long-term safety and efficacy.