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ACTIVE NOT RECRUITING
NCT04023370
NA

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

Sponsor: Bentley InnoMed GmbH

View on ClinicalTrials.gov

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

Official title: Evaluation of the Efficacy and Safety of the Application of BeGraft Peripheral Stent Graft System in Interventional Treatment of Revascularisation for Primary Iliac Artery Stenosis and/or Occlusive Lesions: a Prospective, Multi-centre, Randomised Controlled Clinical Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

182

Start Date

2019-09-19

Completion Date

2025-08-31

Last Updated

2024-10-26

Healthy Volunteers

No

Interventions

DEVICE

Treatment of primary iliac artery stenosis and/or occlusive lesions

Stent implantation

Locations (12)

Beijing Hospital

Beijing, China

Peking University First Hospital

Beijing, China

Peking University People's Hospital

Beijing, China

Peking University Third Hospital

Beijing, China

Shanghai Ninth People's Hospital

Shanghai, China

Suzhou Municipal Hospital

Suzhou, China

The Second Affiliated Hospital of Soochow University

Suzhou, China

General Hospital of Tianjin Medical University

Tianjin, China

The Second Hospital of Tianjin Medical University

Tianjin, China

Tianjin First Center Hospital

Tianjin, China

The Central Hospital of Wuhan

Wuhan, China

The First Hospital of Zhejiang Province

Zhejiang, China