NCT02278991

Bard LifeStent and Lutonix DCB for Treatment of Long Lesions in Femoropopliteal Arteries

A Prospective, Multicenter, Single-Arm, Post-Market Study Using the Lutonix Drug Coated Balloon for Post-Dilatation of the Bard LifeStent Vascular Stent for Treatment of Long Lesions in Femoropopliteal Arteries

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 149 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Objective of this study is to evaluate the safety and efficacy of Lutonix 035 Drug Coated Dilatation PTA Catheter with Bard LifeStent Vascular Stent (hereinafter referred to as LifeStent) for treatment of long (10-24 cm) lesions in the SFA and/or proximal popliteal artery.

Detailed description

The study will observe subjects presenting with claudication or ischemic rest pain (Rutherford category 2-4) and long (10-24 cm in length) native lesions in the infra-inguinal segment (superficial femoral artery \[SFA\] and/or proximal popliteal artery) who are candidates for stenting and pre-/post-dilatation with Drug Coated Balloon (DCB).

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	Lutonix Drug Coated Balloon	Subject will receive treatment with the Lutonix Drug Coated Balloon

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-09-01
• Completion: 2018-10-02
• First posted: 2014-10-30
• Last updated: 2019-10-09

Locations

12 sites across 3 countries: Germany, Greece, Poland