001 - DEEPER LIMUS Trial Update: the Bare Temporary Spur Stent System followed by a Sirolimus-coated Balloon
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.
Material and Methods: The DEEPER LIMUS pilot study is a prospective, non-randomized, single center, single arm trial with follow up at 1, 3, 6, and 12 months. Twenty-six subjects 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 angiogram 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 post procedure.
Results: As of October, 2022, 22 subjects have reached six months follow up and have been evaluated for the primary safety endpoint. One subject underwent CD-TLR at the 6 month timepoint, one subject underwent a major amputation due to infection at 30 days, and one subject died of COVID-19 during the 3 month follow up timepoint [3/22 (13.6%)]. 100% of subjects have met the secondary safety endpoint of freedom from MALE and POD, and 21/22 (95%), and 15/16 (93.8%) of subjects have met the secondary safety endpoint of freedom from MALE at 6 and 12 months, respectively. Patency by duplex ultrasound has been analyzed on the first 22 subjects with diagnostic ultrasounds according to the ultrasound core lab; 19/22 (86%) subjects had patency at 6 months. Patency by angiography has been performed on 18 subjects, with 15/18 (83.3%) of subjects 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 (WIfI) risk scores for subjects 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 Sur Stent System in combination with a commercially available sirolimus coated balloon. Further data is needed to confirm long term safety and efficacy.