Status: Recruiting
IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial
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.
Participants needed: 100
Trial details
Age: 18-85Biological sex: AllType: InterventionalSponsor: Biotyx Medical (Shenzhen) Co., Ltd.Updated: Aug 2, 2023Locations: 1
Eligibility criteria
Subject between 18 and 85 years old. [+9]
Severe renal insufficiency, hepatic dysfunction (Cr > 2 times normal limit or re... [+23]