The study calls for enrolment of real-world patients, allowing inclusion of a diverse patient population with lesion characteristics not typically enrolled in clinical studies – in short, ‘all-comers’ – providing evidence on the role of the Passeo-18 Lux in treating peripheral artery disease in all its complexity.
The registry aims to enrol at least 700 patients at 55 sites from 19 countries in Europe, Asia, Australia and the Pacific, making the results representative of real-world, standard clinical practice. The primary endpoints of the study are freedom from clinically-driven target lesion revascularisation within 12 months as well as freedom from major adverse events. This is measured as a composite of freedom from device- and procedure-related mortality through 30 days, freedom from major target limb amputation and clinically-driven target lesion revascularisation within six months after the index procedure. “In the past, we relied on more specific studies with stringent sets of criteria to examine the effects of Passeo-18 Lux on patients suffering from peripheral artery disease. We are now looking forward to studying the way this drug-releasing balloon works in the real world,” comments Gunnar Tepe, coordinating clinical investigator, Klinikum Rosenheim, Germany.
Almost five% of men and women between the ages of 44 and 74 suffer from occlusions of the peripheral arteries. Left unchecked, the disease can lead to limb amputation. In fact, it is estimated that peripheral occlusive vascular disease causes an estimated 60,000 amputations per year in Germany alone. This study aims to show that Passeo-18 Lux is an effective real-world solution to a pressing health problem.
“Based on positive results from the BIOLUX P-I and BIOLUX P-II randomised controlled trials, we can already confirm that the Passeo-18 Lux DRB is a safe and effective therapy option for above- the-knee arterial disease, and has also demonstrated positive results below-the-knee,” says Alexander Uhl, vice president of marketing, BIOTRONIK Vascular Intervention. “We are confident that these positive results will hold for this all-comers registry, which significantly expands the investigation into our balloon’s capabilities.”