Biotronik CRC Inc.

The BRight PK Study is a prospective, single-arm, open-label, non-blinded, non-randomized study, which goal is to assess the pharmacokinetic profile of the BRight drug-coated balloon at different time points after the balloon deployment.
The study will enroll a maximum of 10 patients at a single site in Australia

The primary aim of this clinical study is to assess the safety and clinical performance of the BRight drug-coated balloon (DCB) in the treatment of lower limb arteries stenosis in subjects with Peripheral Artery Disease (PAD).
The primary endpoint will be Late Lumen Loss (LLL) of the target lesion at 6 months.

Assessment of the safety and clinical performance of a coronary stent system in de novo coronary artery lesions