IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBiotyx Medical (Shenzhen) Co., Ltd.
About this 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.
Eligibility criteria
Qualifiers
Subject between 18 and 85 years old.
Subject who can understand the purpose of the trial, voluntarily participate in, and sign the informed consent form, and who are willing to participate until the 12 months follow-up.
Subject has symptomatic Critical Limb Ischemia, Rutherford category 3-5.
Subject requires primary treatment of de novo infrapopliteal lesions.
Disqualifiers
Severe renal insufficiency, hepatic dysfunction (Cr > 2 times normal limit or renal dialysis, ALT or AST > 5 times normal limit).
Major amputation before index procedure or plan for major amputation.
Any coagulation disorder.
Lower extremity arteries surgery or thrombolytic therapy in the ipsilateral extremity in the past 6 weeks.
Trial design
Treatments tested in this trial
- Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Biotyx Medical (Shenzhen) Co., Ltd.
Lead sponsor
VascuScience GmbH
Collaborator
Mediolanum Cardio Research Srl
Collaborator
Euroimage Research Srl
Collaborator
Source ClinicalTrials.gov