The Medical University of Graz has enrolled the first patient to evaluate Reflow Medical’s Spur Peripheral Retrievable Scaffold System in the DEEPER CHALLENGE study.
The single-centre, investigator-initiated, single-arm prospective study is supported by a grant and aims to assess early vessel recoil after below-the-knee treatment with the Spur device in combination with a drug-coated balloon.
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It is set to include up to 40 patients with chronic limb-threatening ischaemia (CLTI), split between two groups: individuals with diabetes and those with end-stage renal disease who have been receiving haemodialysis for at least six months.
The enrolment criteria specify that women must comprise at least half of each cohort.
Researchers will focus on a better understanding of the immediate mechanical response of blood vessels after endovascular therapy in these patients, who often present with complex lesion morphology and increased risk of restenosis.
The primary outcome is early vessel recoil, measured by angiography within 15 minutes after treatment.
Secondary outcomes include major adverse limb events, mortality and the need for further interventions up to 12 months, as well as hemodynamic results through 30 days.
Medical University of Graz angiology division head and co-investigator professor Marianne Brodmann said: “Patients with end-stage kidney disease or diabetes are often under-represented in CLTI studies, despite facing higher risks of restenosis and limb-threatening ischaemia, while females are under-represented in most medical studies.
“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.”
Reflow Medical global marketing vice-president Dejan Ilic said: “We are pleased to support this investigator-initiated study led by the Medical University of Graz, which addresses important questions in below-the-knee disease.
“The study reflects our continued commitment to collaborating with physicians to advance clinically driven research in high-risk patient populations.”
In July 2024, Reflow Medical enrolled the first patient for a pilot study to assess the Coronary Sirolimus-Eluting Retrievable Scaffold System, known as Spur Elute.
