MedTrace Logo

LEVANT I, The Lutonix Paclitaxel-Coated Balloon for the Prevention of Femoropopliteal Restenosis

NCT00930813 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 101

Last updated 2015-12-21

Study results available
· View outcomes & findings →

Summary

The purpose of the study is to assess the safety and efficacy of the Lutonix Catheter for treatment of stenosis of the femoropopliteal arteries by direct comparison to standard balloon angioplasty.

Conditions

Interventions

DEVICE

Lutonix Catheter

Paclitaxel Coated Balloon Catheter

DEVICE

Standard uncoated Balloon Angioplasty Catheter

plain, uncoated angioplasty balloon catheter

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-06-30
Completion
2011-12-31

Countries

  • Belgium
  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00930813 on ClinicalTrials.gov