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LEVANT Japan Clinical Trial

NCT01816412 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2016-09-28

No results posted yet for this study

Summary

To demonstrate the safety and efficacy of MD02-LDCB for treatment of stenosis or occlusion of the femoral and popliteal arteries in the Japanese population.

Conditions

  • Femoral Arterial Stenosis
  • Stenosis of Popliteal Arteries
  • Femoral Artery Occlusion
  • Occlusion of Popliteal Arteries

Interventions

DEVICE

MD02-LDCB Paclitaxel coated balloon catheter

PROCEDURE

Standard Uncoated Balloon Angioplasty Catheter

Sponsors & Collaborators

  • Medicon, Inc.

    collaborator INDUSTRY

  • C. R. Bard

    lead INDUSTRY

Principal Investigators

  • Hiroyoshi Yokoi · Kokura Memorial Hospital Cardiovascular Internal Medicine

  • Osamu lida · Kansai Rosai Hospital Cardiovascular Internal Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2014-12-31
Completion
2016-06-30

Countries

  • Japan

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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 NCT01816412 on ClinicalTrials.gov