Clinical Trial

IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial

Unknown
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Record status
This record was last updated August 2, 2023 (before its estimated January 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this prospective, multicentre, single arm clinical trial is to assess the safety and effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) in treating patients with infrapopliteal arterial stenosis or occlusive disease. 100 participants will be implanted with IBS Titan™, and be followed up for 1-month, 6-month and 12-month after discharge.
Protocol Amendment History 1 change
critical Trial status changed: Recruiting → Unknown 2026-08-09
Trial Details
NCT Number NCT05971394
Lead Sponsor Biotyx Medical (Shenzhen) Co., Ltd.
Collaborators: VascuScience GmbH, Mediolanum Cardio Research Srl, Euroimage Research Srl
Conditions Infrapopliteal Lesions, Critical Limb Ischemia
Enrollment 100 participants
Start Date 2023-07-17
Primary Completion 2026-01 (estimated)
Study Completion 2026-07 (estimated)
Updated on ClinicalTrials.gov 2023-08-02