Alvimedica’s Illumina study enrolment is now complete. The Illumina study has been designed to evaluate the efficacy and safety of the new NiTiDES self-expanding polymer free drug-eluting stent for the superficial femoral artery, manufactured by CID SpA, a member of Alvimedica group. Currently this device represents the first attempt to embed a controlled and targeted drug elution (two to three months) with a polymer-free nitinol platform.
Illumina is a prospective and single-arm study, which enrolled 100 patients with ischaemic obstruction of the superficial femoral and proximal popliteal arteries. The two co-primary endpoints for the study are primary patency rate at 12 months as the efficacy endpoint, and composite event free survival rate at 12 months as the safety endpoint. The trial principal investigator is Dierk Scheinert from Leipzig University hospital, Leipzig, Germany.
NiTiDES is a polymer free stent-eluting the amphilimus formulation (a combination of sirolimus and fatty acid) through the “Abluminal Reservoir Technology” aiming at obtaining the highest efficacy profile for the patient. The polymer-free platform, which is made of nitinol, is integrally covered by the Bio Inducer Surface coating, a second generation pure carbon “ultra thin” layer that drastically increases haemo- and biocompatibility.
Scheinert explains, “Even though there are stents for the superficial femoral artery that give good results, there is still a need for improvement, especially for the diabetic patient setting where the solutions today available are not providing satisfactory outcomes. Through the Illumina study we will evaluate the innovative NiTiDES device concept and the clinical contribution it will provide for superficial femoral artery interventions.”