NCT02043951

Use and Safety of the LUTONIX® Drug Coated Balloon Catheter in Arteries of the Lower Extremity

A Prospective, Multicenter, Single Arm, Post-Market, Real-World Global Registry Assessing the Clinical Use and Safety of the LUTONIX Drug Coated Balloon Catheter in Arteries of the Lower Extremity (LUTONIX® Lower Extremity Global (LEG) Registry)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 59 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The registry will enroll patients with claudication or critical limb ischemia and angiographically significant lesion(s) in arteries of the lower extremity. Subjects will be treated with the Lutonix® Drug Coated Balloon Catheter for approved indications according to the current country-specific Instructions for Use (IFU) and followed clinically for 1 year.

Detailed description

This post-market registry is intended to assess the clinical use and safety of the Lutonix® Drug Coated Balloon Catheter in a heterogeneous patient population in real world clinical practice. Up to 500 patients will be enrolled in order to allow identification and assessment of rare adverse events (AEs) as well as outcomes in subpopulations defined by subject and lesion characteristics. All subjects will be followed for 1 year. This registry is performed with marketed devices within the indications for use. There are no additional treatments or exams that will take place within this registry.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	Lutonix Drug Coated Balloon Catheter

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-12-01
• Completion: 2016-01-01
• First posted: 2014-01-23
• Last updated: 2016-07-13

Locations

8 sites across 3 countries: Canada, Malaysia, New Zealand