Reflow Medical has enrolled the first patient in the DEEPER CHALLENGE study evaluating its Spur Peripheral Retrievable Scaffold System for below-the-knee treatment in patients with chronic limb-threatening ischemia (CLTI).
The single-center study at the Medical University of Graz will enroll up to 40 patients with diabetes or end-stage renal disease receiving hemodialysis. Investigators will assess early vessel recoil following treatment with the Spur system used in combination with a drug-coated balloon, along with safety and clinical outcomes over 12 months.
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Professor Marianne Brodmann, co-investigator, said:
“This study’s specific inclusion criteria and focus on early vessel recoil will provide insights into the vessel’s immediate mechanical response after endovascular therapy.”
The study aims to generate evidence on the performance of the Spur system in high-risk patient populations that are often underrepresented in peripheral vascular disease research.
