1-Year DEEPER OUS Results Presented for Reflow’s Bare Temporary Spur Stent System

October 31, 2023—The DEEPER OUS trial is evaluating the safety and efficacy of the Bare Temporary Spur stent system (Reflow Medical) used in conjunction with a commercially available drug-coated balloon (DCB) to treat patients with symptomatic infrapopliteal arterial disease.

The prospective, nonrandomized, multicenter, single-arm trial is being conducted in New Zealand, Germany, and Switzerland. In-person follow-up occurs at 1, 3, 6, and 12 months postprocedure, with telephone call follow-up annually out to 5 years.

Thomas Zeller, MD, presented 1-year results from DEEPER OUS during a late-breaking clinical trial session at VIVA23, the Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on October 30 to November 2 in Las Vegas, Nevada.

According to the VIVA press release, the trial enrolled 107 patients. Lesion characteristics showed an average treated length of 92.7 ± 36.63 mm, and the most commonly used Spur size was 3 X 60 mm, with an average reference vessel diameter of 3.1 ± 0.48 mm. Approximately 60% of vessels were mildly calcified, with the most common TASC classification being class B (37.2%, 51/106).

The primary efficacy endpoint is primary patency of treated lesion sites by duplex ultrasound in patients who are free from clinically driven target lesion revascularization (CD-TLR) at 6 months.

The primary safety endpoint is freedom from device- and procedure-related death through 30 days postprocedure.

Secondary endpoints include safety-related and clinical outcome measures.

As reported at VIVA, outcomes at 12 months in the per-protocol population are the following:

• Target lesion primary patency was achieved in 57/71 (79.2%).
• Freedom from CD-TLR was achieved in 71/80 (88.8%).

The secondary efficacy endpoint of improvement in Rutherford class showed statistically significant improvement from baseline through 12 months.

The secondary efficacy endpoint of wound healing showed improvement from baseline through 12 months, with approximately 60% of wounds achieving total wound healing.

Analysis of the secondary safety endpoint of freedom from major amputation of the target limb at 12 months was 78/78 (100%).

The Bare Temporary Spur stent system is safe and effective for the treatment of infrapopliteal arterial disease when used in conjunction with a commercially available DCB, concluded Dr. Zeller at VIVA.