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Trial will evaluate efficacy of combined drug-releasing balloon, self-expanding stent

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Enrollment has started for the BIOLUX 4EVER trial, which will assess the combined use of a drug-releasing balloon and a self-expanding stent for the treatment of superficial femoral artery lesions, according to a press release.

The trial will enroll 120 patients who will receive both the Pulsar-18 self-expanding stent and the Passeo-18 Lux drug-releasing balloon (both Biotronik). The primary endpoint is primary patency at 12 months.

The BIOLUX 4EVER trial follows results of prior studies that assessed the efficacy of the self-expanding stent and drug-releasing balloon alone. The previously completed 4EVER trial evaluated the efficacy of the self-expanding stent in 120 patients with superficial femoral artery lesions. At 24 months, the primary patency rate was 72.3% and 82.7% of patients were free from target vessel revascularization, with no significant difference between calcified and noncalcified lesions.

“Studying these two devices in combination is a novel idea,” principal investigator Marc Bosiers, MD, of St. Blasius Hospital in Dendermonde, Belgium, said in the release. “Previous studies of each device have yielded encouraging results, but we wanted to go one step further.”