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

Inclusion criteria

• General criteria

• 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.

• Angiographic criteria
• Target lesion stenosis ≥ 70% or occlusion in no more than two infrapopliteal arteries.
• The distal margin of the target lesion must be located ≥ 10 cm proximal to the proximal margin of the ankle mortise.
• The target lesion must be located in the proximal 2/3 of native infrapopliteal vessels, length is ≤ 200mm, with vessel diameter of 2.5-4 mm.
• Only two infrapopliteal vessels are allowed to be treated at the same time.
• A maximum of two stents can be deployed at one target vessel.
• There must be at least one unimpaired artery (< 30% stenosis) to the ankle.

Exclusion criteria

• General criteria：

• 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.
• Stroke within 3 months, or stroke with severe hemiplegia and aphasia sequelae more than 3 months before inclusion in the study.
• Acute myocardial infarction or acute ischemia within 30 days before inclusion in the study.
• Thromboangiitis obliterans (Buerger's disease).
• Any previous treatment with drug eluting balloon or drug eluting stent within 90 days before inclusion.
• Any surgery in target vessel before index procedure.
• Volume reduction operation in target vessel before inclusion.
• Subject known to be allergic to aspirin, heparin, clopidogrel, Polylactic acid, iron, zinc and its degradation products, contrast agents, sirolimus, etc., and those who cannot tolerate postoperative dual anti-platelet therapy.
• Subject with a history of iron overload or iron disorders related diseases, such as hereditary hemochromatosis, etc.
• Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
• Women of child-bearing potential not using an effective contraception; pregnant or lactating women.
• Subject is not suitable to participate in the trial as per investigators discretion.
• Life expectancy ≤ 12 months as per investigators judgement.

• Angiographic criteria
• The inflow tract (including ipsilateral iliac artery, femoral artery, popliteal artery) has lumen stenosis >30% with or without intervention.
• The inflow tract (including ipsilateral iliac artery, femoral artery, popliteal artery) has > 150 mm stenosis or occlusion before treatment.
• Significant stenosis (≥50% stenosis) of the arterial outflow tract perfused by the target vessel.
• In-stent restenosis in any lower extremity artery.
• Thrombosis in target vessel, or acute thrombosis requiring thrombolysis and thrombectomy.
• Guide wire cannot pass target lesion.
• Angiography suggests intraoperative thromboendarterectomy, percutaneous transluminal rotational atherectomy or laser therapy are needed.
• Aneurysm of lower extremity artery in the ipsilateral leg.