BIOLUX P-IV CHINA ( BIOTRONIK )

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02912715
Study type	Interventional
Source	Biotronik (Beijing) Medical Device Ltd.
Contact
Status	Completed
Phase	N/A
Start date	October 2016
Completion date	August 2020

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