NCT01790243

LEVANT 2 Safety Registry

A Prospective, Multicenter, Registry of the Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries (LEVANT 2 Safety Registry)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,189 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the LEVANT 2 Extended Follow-up Post-Approval Study (PAS 1) is to evaluate the long-term performance of the Lutonix Drug Coated Balloon (DCB) versus Percutaneous Transluminal Balloon Angioplasty (PTA) in the treatment of stenosis or occlusion of the femoropopliteal arteries.

Conditions

• Peripheral Artery Disease
• Femoropopliteal Artery Occlusion
• Femoropopliteal Stenosis

Interventions

Type	Name	Description
DEVICE	Lutonix Drug Coated Balloon	Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.
DEVICE	Standard PTA Balloon	Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.

Timeline

• Start date: 2011-07-20
• Primary completion: 2015-11-27
• Completion: 2018-11-01
• First posted: 2013-02-13
• Last updated: 2020-06-05
• Results posted: 2020-06-05

Locations

8 sites across 1 country: United States