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A Prospective, Multi-centre, Randomized Controlled, First in Man Study to Assess the Safety and Performance of the Passeo-18 Lux Paclitaxel Releasing PTA Balloon Catheter vs. the Uncoated Passeo 18 Balloon Catheter in Patients With Stenosis and Occlusion of the Femoropopliteal Arteries (BIOLUX P-I).

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Trial Profile

A Prospective, Multi-centre, Randomized Controlled, First in Man Study to Assess the Safety and Performance of the Passeo-18 Lux Paclitaxel Releasing PTA Balloon Catheter vs. the Uncoated Passeo 18 Balloon Catheter in Patients With Stenosis and Occlusion of the Femoropopliteal Arteries (BIOLUX P-I).

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 12 Feb 2015

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At a glance

  • Drugs Paclitaxel (Primary)
  • Indications Peripheral arterial occlusive disorders
  • Focus First in man; Therapeutic Use
  • Acronyms BIOLUX P-I
  • Sponsors BIOTRONIK

Most Recent Events

  • 04 Dec 2014 New trial record

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