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Status:

RECRUITING

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

Lead Sponsor:

Biotyx Medical (Shenzhen) Co., Ltd.

Collaborating Sponsors:

VascuScience GmbH

Mediolanum Cardio Research Srl

Conditions:

Infrapopliteal Lesions

Critical Limb Ischemia

Eligibility:

All Genders

18-85 years

Phase:

NA

Brief 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 treati...

Eligibility Criteria

Inclusion

  • • 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

  • • 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.

Key Trial Info

Start Date :

July 17 2023

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

July 1 2026

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT05971394

Start Date

July 17 2023

End Date

July 1 2026

Last Update

August 2 2023

Active Locations (1)

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Azienda Ospedaliero Universitaria Careggi

Florence, Italy