NCT02554266

Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries

A Prospective, Multicenter, Single Arm Real-World Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon Percutaneous Transluminal Angioplasty (PTA) Catheter for Treatment of Below-the-Knee (BTK) Arteries

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 371 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropriate for angioplasty that is below the knee. Subjects will be treated with the Lutonix Drug Coated Balloon (DCB) carrying the CE Mark per current IFU and followed clinically for a minimum of 2 years.

Detailed description

Patients will be treated according to hospital routine with anticipated visits 30 days, 6 months, 12months and 24 months after the index procedure. Data on Rutherford grade, wound healing, patency of the target lesion, concomitant antiplatelet medication and Adverse Events will be collected.

Conditions

• Peripheral Artery Disease

Interventions

Type	Name	Description
DEVICE	Lutonix 014 Drug Coated Balloon PTA Catheter	Drug Coated Balloon PTA Catheter for Treatment of Below-the-Knee (BTK) Arteries

Timeline

• Start date: 2015-09-29
• Primary completion: 2018-05-31
• Completion: 2019-11-22
• First posted: 2015-09-18
• Last updated: 2020-01-13

Locations

26 sites across 11 countries: Austria, Belgium, France, Germany, Greece, Italy, Portugal, Saudi Arabia, Spain, Switzerland, United Kingdom