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A Study of The Femoral Popliteal Artery Treated With LEGFLOW OTW

NCT02965677 · 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 with the standard balloon (Admiral Xtreme) for the treatment of stenosis or occlusions in femoral popliteal artery.

Conditions

  • Peripheral Arterial Disease

Interventions

DEVICE

Paclitaxel Releasing Peripheral Balloon Dilatation Catheter

in this group the subject will be treated by Paclitaxel Eluting Balloon Dilatation Catheter

DEVICE

Peripheral Balloon Dilatation Catheter

in this group the subject will be treated by Paclitaxel Eluting Balloon Dilatation Catheter

Sponsors & Collaborators

  • ZhuHai Cardionovum Medical Device Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Guo Wei, professor · Chinese PLA Genral 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
2016-12-31
Primary Completion
2020-12-31
Completion
2021-06-30

Countries

  • China

Study Locations

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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 NCT02965677 on ClinicalTrials.gov