BIOLUX P-I First in Man Study

Status Completed

Clinical Trial Summary

A prospective, multi-centre, randomized controlled, First in Man study to assess the safety and performance of the coated Passeo-18 Lux Paclitaxel releasing PTA Balloon Catheter vs. an uncoated balloon catheter in patients with stenosis and occlusion of the femoropopliteal arteries.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01221610
Study type	Interventional
Source	Biotronik AG
Contact
Status	Completed
Phase	N/A
Start date	October 2010
Completion date	January 2013

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