Two-Year Results Published From ILLUMENATE FIH Study of Spectranetics' Stellarex DCB

April 13, 2015—Two-year outcomes from the ILLUMENATE first-in-human (FIH) study are available online ahead of print in Catheterization and Cardiovascular Interventions. Henrik Schroeder, MD, et al conducted the ILLUMENATE FIH study to assess the safety and effectiveness of the low-dose Stellarex drug-coated angioplasty balloon (DCB; Spectranetics Corporation) to inhibit restenosis in the superficial femoral and/or popliteal artery.

The ILLUMENATE FIH investigators concluded that the Stellarex DCB provides safe and durable clinical outcomes for treatment of femoropopliteal artery disease through 24 months. The data were presented in May 2014 at the EuroPCR 2014 congress in Paris, France. 

As summarized in Catheterization and Cardiovascular Interventions, the prospective, single-arm, multicenter ILLUMENATE FIH study enrolled 50 patients with 58 lesions in the first cohort that required predilatation with an uncoated angioplasty balloon before inflation of the DCB. The primary effectiveness endpoint was 6-month late lumen loss (LLL). The major secondary endpoint was major adverse event (MAE) rate at 6 months, defined as cardiovascular death, amputation, and/or ischemia-driven target lesion revascularization.

The mean lesion length was 7.2 cm, and baseline stenosis was 75.1%. Calcification was present in 62.1% of lesions, and 12.1% were occluded. Both endpoints met their prespecified performance goals; at 6 months, the MAE rate was 4% and the mean LLL was 0.54 mm. The primary patency rate was 89.5% at 12 months and 80.3% at 24 months. The freedom from clinically driven target lesion revascularization rate, per Kaplan-Meier estimate, was 90% at 12 months and 85.8% at 24 months. Additionally, there were no amputations or cardiovascular deaths reported through 24 months, reported the ILLUMENATE FIH investigators in Catheterization and Cardiovascular Interventions.

Spectranetics acquired the Stellarex DCB from Covidien in January 2015 upon closure of Covidien’s acquisition by Medtronic, Inc. (now Medtronic plc). Stellarex then launched the device in Europe, where it had received CE Mark approval in December 2014.