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LEVANT 2 Continuation Registry of the Lutonix® Drug Coated Balloon (DCB)

NCT01628159 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 657

Last updated 2020-04-10

Study results available
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Summary

The purpose of the study is to collect additional safety and efficacy information on the Lutonix (formerly Moxy) Drug Coated Balloon for treatment of stenosis or occlusion of the femoral and popliteal arteries.

Conditions

Interventions

DEVICE

Lutonix Drug Coated Balloon

balloon angioplasty with a drug coated balloon

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Kenneth Rosenfield, MD · Massachusetts General Hospital

  • Prof. Dierk Scheinert, MD · University Leipzig

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2018-09-30
Completion
2018-12-31

Countries

  • United States
  • Austria
  • Belgium
  • Germany
  • Switzerland

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 NCT01628159 on ClinicalTrials.gov