Alvimedica’s Illumina study has completed enrolment. The Illumina study has been designed to evaluate the efficacy and safety of the new self-expanding polymer free drug eluting stent—NitiDES—for superficial femoral artery, manufactured by CID, a member of Alvimedica group. Currently this device represents the first attempt to embed a controlled and targeted drug elution (2-3 months) with a polymer-free nitinol platform, according to a company release.
Illumina is a prospective and single-arm study, which enrolled 100 patients with ischaemic obstruction of superficial femoral artery and proximal popliteal artery. The two co-primary endpoints for the study are primary patency rate at 12 months—efficacy endpoint, and composite event free survival rate at 12 months—safety endpoint. The trial principle 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 bio-compatibility.
Dierk Scheinert, principal investigator of the Illumina study, states, “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.”