NCT04525794

BRight DCB First-in-Human Study

BIOTRONIK- First-in-Human Assessment of the Safety and Clinical Performance of a Sirolimus Derivative-Coated Balloon (BRight DCB) in the Treatment of Subjects With de Novo Lesions in the Superficial Femoral and Proximal Popliteal Artery (BRight First Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Biotronik CRC Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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: 2021-02-04
• Primary completion: 2023-09-20
• Completion: 2024-02-02
• First posted: 2020-08-25
• Last updated: 2024-05-22

Locations

7 sites across 4 countries: Australia, Austria, Germany, New Zealand