NCT02013271

Lutonix® DCB for Treatment of Long Lesions in Femoropopliteal Arteries

A Prospective, Multicenter, Single-Arm Trial With the Lutonix Drug Coated Balloon for Treatment of Long Lesions in Femoropopliteal Arteries

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 125 (actual)
• Sponsor: C. R. Bard · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To demonstrate efficacy and safety of the Lutonix® Drug Coated Balloon for treatment of long TASC II Class C and D lesions (≥ 14 cm) lesions in the SFA

Detailed description

The study will enroll patients presenting with claudication or ischemic rest pain (Rutherford Category 2-4) and TASC II Class C or D lesions ≥14 cm in length in the native femoropopliteal artery. After successful pre-dilatation (1mm \< RVD) and spot stenting (if necessary, with length minimized to mechanical defect), subjects will receive treatment with the Lutonix Drug Coated Balloon (DCB). The primary safety and efficacy endpoint assessments are performed at 12 months. Clinical follow-up continues through a minimum of 2 years and telephone follow-up through a minimum of 3 years.

Conditions

• Femoral Artery Occlusion
• Femoral Arterial Stenosis

Interventions

Type	Name	Description
DEVICE	Lutonix Paclitaxel Drug Coated Balloon (DCB)	Patients exposed to the DCB as part of their routine care.

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-05-23
• Completion: 2018-06-13
• First posted: 2013-12-17
• Last updated: 2019-10-08

Locations

14 sites across 5 countries: Austria, Belgium, France, Germany, Switzerland