Clinical Trial

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

Active, Not Recruiting
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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
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2019-07-16; most recent amendment 2024-10-24.
Status change: Recruiting → Active, Not Recruiting 2023-06-19
Status change: Not Yet Recruiting → Recruiting 2019-10-07
Trial Details
NCT Number NCT04023370
Lead Sponsor Bentley InnoMed GmbH
Collaborators: Shanghai Micro Medical Devices Co., Ltd.
Conditions Iliac Artery Stenosis
Enrollment 182 participants
Start Date 2019-09-19
Primary Completion 2022-09-30 (estimated)
Study Completion 2025-08-31 (estimated)
Updated on ClinicalTrials.gov 2024-10-26