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LEVANT 2 Safety Registry

NCT01790243 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1189

Last updated 2020-06-05

Study results available
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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

Interventions

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.

Sponsors & Collaborators

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Kenneth Rosenfield, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-20
Primary Completion
2015-11-27
Completion
2018-11-01

Countries

  • United States

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 NCT01790243 on ClinicalTrials.gov