The Illumina study has been designed to evaluate the efficacy and safety of the new self-expanding polymer free drug eluting stent – NiTiDES – for SFA manufactured by CID S.p.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.
Illumina is a prospective and single arm study, which enrolled 100 patients with ischemic obstruction of SFA 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 Prof. Dierk Scheinert from Leipzig University hospital.
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 2nd generation pure carbon ultra thin layer that drastically increases haemo and bio-compatibility.
- SAFETY: Composite event–free survival at 12 months: freedom from CEC adjudicated MAE (death, target limb amputation, target limb ischemia requiring surgical intervention or surgical repair of target vessel or clinically-driven target lesion revascularization) and freedom from worsening of the Rutherford score by 2 classes, or to class 5 or 6
- EFFICACY: Primary patency at 12 months. Primary patency is defined as absence of clinically-driven target lesion revascularization or binary restenosis. Binary restenosis is defined as a peak systolic velocity ratio (PSVR) >2.4 (duplex evaluation)
Italy, France, Germany
11 centers managed by CERC.