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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)
DeviceSubjects in this arm will be treated with Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: IBS TitanExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Freedom from Primary Efficacy Failure
Defined as freedom from the composite of total occlusion of target lesion and clinically driven target lesion revascularization (CD-TLR), and freedom from major amputation.
Time frame
6 monthsSecondary outcomes
1
Major adverse event (MAE)
Defined as a composite of all-cause mortality, CD-TLR and major amputation of target limb.
Time frame
1 month, 6 months, 12 months2
Rate of Device success
Stent level analysis, based on single stent. Defined as the achievement of successful delivery, deployment of stent at the intended infrapopliteal target site(s) and successful withdrawal of the delivery catheter.
Time frame
Immediately post-procedure3
Rate of Technical success
Defined as the restoration of blood flow in the target vessel and angiogram indicates the residual stenosis \<30%.
Time frame
Immediately post-procedure4
Rate of Procedural success
Defined as the combination of technical success, device success, and absence of procedural complications.
Time frame
Immediately post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Biotyx Medical (Shenzhen) Co., Ltd.
Lead sponsor
VascuScience GmbH
Collaborator
Mediolanum Cardio Research Srl
Collaborator
Euroimage Research Srl
Collaborator
Source ClinicalTrials.gov