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Evaluation of the Efficacy and Safety of the Application of BeGraft Peripheral Stent Graft System

NCT04023370 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2024-10-26

No results posted yet for this study

Summary

The trial will be conducted to evaluate the safety and efficacy of the BeGraft Peripheral Stent Graft System in interventional revascularisation for subjects with primary iliac artery stenosis and/or occlusive lesions by conducting a multi-centre, randomised controlled clinical study with a bare metal stent system as the control, thus providing a basis for the formal use of the product in China

Conditions

  • Iliac Artery Stenosis

Interventions

DEVICE

Treatment of primary iliac artery stenosis and/or occlusive lesions

Stent implantation

Sponsors & Collaborators

  • Shanghai Micro Medical Devices Co., Ltd.

    collaborator UNKNOWN

  • Bentley InnoMed GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-19
Primary Completion
2022-09-30
Completion
2025-08-31

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 NCT04023370 on ClinicalTrials.gov