NCT06065345

BRight Pharmacokinetic Study

BIOTRONIK- Pharmacokinetic Study of a Sirolimus Derivative-Coated Balloon (BRight DCB) in the Superficial Femoral and Proximal Popliteal Artery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Biotronik CRC Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	BRight DCB	The BRight Drug-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon catheter (BRight DCB) is intended for dilatation of de novo lesions in native superficial femoral or popliteal arteries with a simultaneous release of drug to the vessel wall as a secondary action to reduce occurrence of a restenosis of the treated vessel segment.

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-06-27
• Completion: 2025-07-22
• First posted: 2023-10-03
• Last updated: 2025-09-05

Locations

1 site across 1 country: Australia