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Evaluation of the Efficacy and Safety of the Application of BeGraft Peripheral Stent Graft System
Sponsor: Bentley InnoMed GmbH
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
Conditions
Interventions
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