Prakash Krishnan, Mount Sinai Medical Center, New York, USA, presented the second interim analysis of 12-month data from the ILLUMENATE Global Study at the New Cardiovascular Horizons (NCVH) annual conference (1–3 June, New Orleans, USA). The ILLUMENATE Global Study is a prospective, multicentre, single-arm study designed to assess the clinical performance of the Stellarex drug-coated balloon (DCB) in the superficial femoral and popliteal arteries.
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 is a key and objective indicator of clinical effectiveness. Freedom from clinically-driven target lesion revascularisation (TLR) was 93.9% at both day 360 and 365. These interim results, which include a larger number of patients, are consistent with the initial ILLUMENATE Global 12-month interim analysis and the ILLUMENATE First-In-Human Study results.
“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 randomised data later this year,” said Krishnan.
“Spectranetics is committed to providing our customers with robust, high quality clinical data in a timely manner to facilitate evidence-based decisions. We are proud to have collaborated with some of the top opinion leaders in the United States and Europe, and are pleased that the second interim analysis supports our top-tier ILLUMENATE First-in-Human Study data,” said Scott Drake, president and CEO.
The ILLUMENATE Global 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 (CEC) to adjudicate adverse events.
The Stellarex DCB is designed to restore and maintain blood flow to the superficial femoral and popliteal arteries in patients with peripheral arterial disease. Spectranetics launched the device in Europe in January 2015, with US commercialisation anticipated in the 2017 timeframe.
The Stellarex DCB platform is designed to treat peripheral arterial disease. The Stellarex DCB uses EnduraCoat technology, a durable, uniform coating designed to prevent drug loss during transit and facilitate controlled, efficient drug delivery to the treatment site. The Stellarex DCB platform received CE mark to be marketed in the European Union in December 2014. It is not for sale in the United States.
About ILLUMENATE Global Study
The ILLUMENATE Global Study is a prospective, single-arm, multicenter study that enrolled 371 patients at 37 centers inEurope, Australia and New Zealand. This study is being conducted with a high level of rigor to ensure data is unbiased and accurate. Oversight includes review by angiographic and duplex ultrasound core laboratories, monitoring of all data and oversight by a clinical events committee and a data safety monitoring board. Follow-up assessments include a duplex ultrasound for patency assessment, functional outcome questionnaires (EQ-5D and WIQ), an ABI and RCC assessment, and adverse event evaluations. Patients will be followed for up to five years.
About ILLUMENATE clinical trials
There are five clinical studies evaluating the safety and effectiveness of the Stellarex DCB platform and support United States and Canadian regulatory filings. There are four ILLUMENATE clinical studies in addition to the ILLUMENATE Global Study described above:
- The ILLUMENATE First-In-Human (FIH) Study was a non-randomised, multicentre study that enrolled 80 patients. In the pre-dilatation arm (n=50), the primary patency rate at 12 months was 89.5% and 80.3% at 24 months. The freedom from clinically driven target lesion revascularisation rate at 12 months was 90.0% and 85.8% at 24 months.
- The ILLUMENATE Pharmacokinetic Study measured the paclitaxel drug levels in the blood of 25 patients enrolled at two sites.
- The ILLUMENATE Pivotal Study is a prospective, randomised controlled, multicenter trial with 300 patients enrolled at 43 sites to support US FDA approval. Results are expected to be released later this year.
- The ILLUMENATE European Randomised Trial is a prospective, randomised controlled, multicentre trial with 328 patients enrolled at 18 sites. Results are expected to be released later this year.