Second Interim Analysis of ILLUMENATE Global Study Presented for Spectranetics' Stellarex DCB

June 1, 2016—Spectranetics Corporation announced that an interim analysis of 12-month data from the ILLUMENATE Global Study was presented by Prakash Krishnan, MD, at the New Cardiovascular Horizons annual conference held June 1–3 in New Orleans, Louisiana. The ILLUMENATE Global Study is a prospective, multicenter, single-arm study designed to assess the clinical performance of the company’s Stellarex drug-coated balloon (DCB) in the superficial femoral and popliteal arteries.

According to Spectranetics, the interim results from 220 patients (247 lesions) of the 371 patients enrolled demonstrated a primary patency rate of 90.3% at day 360 and 86.5% at day 365. Primary patency indicates the device’s clinical effectiveness. Freedom from clinically driven target lesion revascularization (TLR) was 93.9% at both day 360 and day 365.

In the announcement, Dr. Krishnan commented, “The patency rates from this interim data are top tier and compare well with the highest DCB patency rates in comparable clinical studies. The fact that these results were achieved with a low-dose DCB is especially compelling. This analysis supports the promising data generated in the first-In-human study, and I look forward to seeing the randomized data later this year.” Dr. Krishnan is with Mount Sinai Medical Center in New York, New York.

Spectranetics advised that these interim results, which include a larger number of patients, are consistent with the study's initial 12-month interim analysis presented in April 2016 by Global Principal Investigator Prof. Thomas Zeller, MD, at the Charing Cross Symposium in London, United Kingdom. They are also consistent with results from the ILLUMENATE First-In-Human Study published in 2015 by Henrik Schroeder, MD, et al in Catheterization and Cardiovascular Interventions (2015;86:278-286).

The ILLUMENATE Global Study is a prospective, single-arm, multicenter study that enrolled 371 patients at 37 centers in Europe, Australia, and New Zealand. The company noted that the study is being conducted with a high level of rigor including angiographic and duplex ultrasound core lab assessments, as well as an independent clinical events committee to adjudicate adverse events. Patients will be followed for up to 5 years.

The Stellarex DCB platform received European CE Mark approval in December 2014 and was launched in Europe in January 2015. Currently, the device is not for sale in the United States. Spectranetics anticipates United States commercialization in 2017. Additional analysis on the Stellarex DCB will be released later this year. There are four other clinical studies evaluating the safety and effectiveness of the Stellarex DCB platform to support United States and Canadian regulatory filings, advised the company.