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

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv4
  2. Primary completion date changed from estimate of Aug 31, 2020 to Sep 30, 2022
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 12 of 12 sites
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 12
    • Start date changed from estimate of Aug 1, 2019 to Sep 19, 2019
    • Study description shortened, about 2 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT04023370
Lead Sponsor Bentley InnoMed GmbH
Collaborators: Shanghai Micro Medical Devices Co., Ltd.
Conditions
(from sponsor)		 Iliac Artery Stenosis
Enrollment 182 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov