Lutonix® DCB for Treatment of Long Lesions in Femoropopliteal Arteries

Status Completed

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02013271
Study type	Observational
Source	C. R. Bard
Contact
Status	Completed
Phase
Start date	December 2013
Completion date	June 13, 2018

View Details

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