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Study of Drug Eluting Peripheral Vascular Stent System in Superficial Femoral Artery Stenosis and /or Occlusion

NCT03121430 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2019-02-18

No results posted yet for this study

Summary

Evaluation of drug eluting peripheral vascular stent system for the treatment of superficial femoral artery stenosis and / or occlusion, there is better in effectiveness and clinical performance compared with similar products already on the market.

Conditions

  • Peripheral Arterial Disease
  • Superficial Femoral Artery Stenosis
  • Superficial Femoral Artery Occlusion

Interventions

DEVICE

Drug eluting peripheral vascular stent system

Drug eluting peripheral vascular stent system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）

DEVICE

Nitinol Stent System

Nitinol Stent System、Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）

Sponsors & Collaborators

  • Guangzhou Osmunda Medical Device Technology, Inc., Ltd.

    collaborator INDUSTRY

  • Zhejiang Zylox Medical Device Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chen Zhong · Beijing Anzhen Hospital

  • Guo Wei · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-10-22
Primary Completion
2020-07-31
Completion
2021-02-28

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 NCT03121430 on ClinicalTrials.gov