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Safety and Efficacy Study of GoldenFlow Peripheral Stent System

NCT03687983 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2018-09-27

No results posted yet for this study

Summary

A Prospective, Multi-center, Single-Arm Clinical Trial to evaluate the safety and efficacy of the GodenFlow Peripheral Stent System manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for lower limb artery stenosis or occlusion diseases.

Conditions

  • Iliac Artery Stenosis
  • Iliac Artery Occlusion
  • Femoral Artery Stenosis
  • Femoral Artery Occlusion
  • Popliteal Arterial Stenosis
  • Popliteal Artery Occlusion

Interventions

DEVICE

GoldenFlow Peripheral Stent System

Performing anaesthetic and pathological angiography according to the standard method, and select appropriate stent specifications according to the contrast results. After 1:1 pre-expansion, the stent system will be imparted into the lesion location, the stent will be distally positioned and released. The Tip head will be reset and the conveyor will be removed. If necessary, local re-expansion can be carried out. Remove the catheter and suture the wound. Postoperative treatment and anticoagulation.

Sponsors & Collaborators

  • Lifetech Scientific (Shenzhen) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhong Chen, Professor · Beijing Anzhen Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-05-11
Primary Completion
2019-09-30
Completion
2019-12-31

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 NCT03687983 on ClinicalTrials.gov