ILLUMENATE FIH demonstrates importance of vessel preparation with Stellarex drug-coated balloon

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At the Leipzig Interventional Course (LINC 2015), Stephan Duda presented findings from the ILLUMENATE FIH (first-in-human) study that demonstrate primary patency at 12 months of 89.5% in the pre-dilation plus drug-coated balloon group and 77.5% in the direct balloon group, when using the Stellarex drug-coated balloon.

The ILLUMENATE FIH study is a prospective, multicentre study designed to assess the clinical performance of the Stellarex drug-coated angioplasty balloon (Spectranetics) used to restore and maintain blood flow to the arteries of the leg in patients with peripheral arterial disease.

Duda, from Jüdisches Krankenhaus Berlin, Germany, said that the data include results on the 50 pre-dilated and 22 direct drug-coated balloon patients studied.

The study reported a primary patency (defined as the treated artery remaining open without further treatment required or renewed blockage detected by ultrasound scanning) of 89.5% in the pre-dilation plus balloon group and 77.5% in the direct balloon group at 12 months. The freedom from clinically driven target lesion revascularisation rate at 12 months was 90% in the pre-dilation plus balloon group and 85.4% in the direct balloon group (p=0.5396). Duda added that the primary patency of 80.3% in the pre-dilation plus balloon group at 24 months demonstrates continued durability of the procedure. There were no major amputations or cardiovascular deaths in either group. At six months, the late lumen loss was 0.08 in the direct balloon cohort and 0.54 in the dilation plus balloon group, which shows, according to Duda, a “good drug effect”.

The study’s average lesion length was approximately 7.2cm in pre-dilated patients and 6.4cm in the direct balloon patients.

Duda states, “When it comes to patient care, physicians demand proven clinical results that show positive outcomes. With freedom from clinically driven target lesion revascularisation at 90% in the pre-dilation plus balloon group and 85.4% in the direct balloon group, this trial has proven results that will impact the choice of treatment.”

The Stellarex platform received CE mark approval in December 2014. Spectranetics has now launched the product in Europe, with US commercialisation anticipated in 2017, following FDA approval.