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A Study of Below The Knee Arteries' Stenosis or Occlusion Treated With LEGFLOW OTW

NCT02962232 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2018-11-29

No results posted yet for this study

Summary

To evaluate the safety and efficacy of the Paclitaxel Releasing Peripheral Balloon Dilatation Catheter (LEGFLOW) compared to the PTA catheter (AMPHIRION DEEP) in treatment of stenosis or occlusion in below the knee artery.

Conditions

Interventions

DEVICE

Paclitaxel Releasing Peripheral Balloon Dilatation Catheter

treatment group

DEVICE

PTA catheter

control group

Sponsors & Collaborators

  • ZhuHai Cardionovum Medical Device Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chen zhong, professor · Beijing Anzhen Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2020-06-30
Completion
2020-12-31

Countries

  • China

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 NCT02962232 on ClinicalTrials.gov