NCT02912715

BIOLUX P-IV CHINA ( BIOTRONIK )

Prospective, Multi-center, Non-randomized Clinical Trial of Passeo-18 Lux Drug Coated Balloon（DCB） in New and Non-stented Re-stenotic Lesions in the Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA) in a Chinese Patient Population

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 158 (actual)
• Sponsor: Biotronik (Beijing) Medical Device Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multi-center, non-randomized clinical trial with follow-up investigations at 1, 6 and 12 months. To confirm safety and efficacy of Passeo-18 Lux DCB in new and non-stented re-stenotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) in a Chinese patient population.

Detailed description

A prospective, multi-centre, non-randomized clinical trial with follow-up investigations at 1, 6 and 12 months. Approximately 158 subjects will be enrolled at 15 Chinese study sites. To confirm the safety and efficacy of the Passeo-18 Lux DCB for the interventional treatment of new and non-stented re-stenotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) in a Chinese patient population.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Paclitaxel releasing angioplasty balloon	Paclitaxel releasing angioplasty balloon catheter is advanced through an introducer sheath and tracked over the wire until reaching the target lesion. The balloon can be precisely positioned by means of the radiopaque markers crimped on the inner shaft of the catheter. The catheter is dilated up to its intended diameter by inflating the balloon with a solution containing contrast media, causing a compression of the arterial plaque against the inner lining of the arterial wall and improving blood flow. After balloon inflation, the drug-carrier adheres to the arterial wall and facilitates the drug release to surrounding tissue. As there is no need for sustained release of Paclitaxel after the inflation, the drug carrier dissolves rapidly.

Timeline

• Start date: 2016-10-01
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2016-09-23
• Last updated: 2023-08-21

Locations

1 site across 1 country: China