Treatment for critical limb ischemia using a bioresorbable scaffold system

A Prospective, Multicentre, Single Arm Clinical Trial 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

This study is testing a new device to see if it can improve blood flow and reduce symptoms in people with severe leg circulation problems caused by blocked arteries.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: Biotyx Medical (Shenzhen) Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Florence)
• Trial ID: NCT05971394 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of the IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System in patients suffering from infrapopliteal arterial stenosis or occlusive disease. A total of 100 participants will receive the scaffold system and will be monitored for outcomes at 1, 6, and 12 months post-implantation. The study is designed as a prospective, multicentre, single-arm trial, focusing on patients with symptomatic critical limb ischemia. The goal is to determine how well this innovative treatment can improve blood flow and alleviate symptoms in affected individuals.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 85 with symptomatic critical limb ischemia requiring treatment for infrapopliteal lesions.

Not a fit: Patients with less severe forms of limb ischemia or those with extensive arterial disease may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve blood flow and reduce symptoms for patients with critical limb ischemia.

How similar studies have performed: While this approach is innovative, similar studies using bioresorbable scaffolds have shown promise in other vascular conditions.

Eligibility criteria

Inclusion Criteria:

• General criteria

1. Subject between 18 and 85 years old.
2. 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.
3. Subject has symptomatic Critical Limb Ischemia, Rutherford category 3-5.
4. Subject requires primary treatment of de novo infrapopliteal lesions.

   • Angiographic criteria
5. Target lesion stenosis ≥ 70% or occlusion in no more than two infrapopliteal arteries.
6. The distal margin of the target lesion must be located ≥ 10 cm proximal to the proximal margin of the ankle mortise.
7. 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.
8. Only two infrapopliteal vessels are allowed to be treated at the same time.
9. A maximum of two stents can be deployed at one target vessel.
10. There must be at least one unimpaired artery (\< 30% stenosis) to the ankle.

Exclusion Criteria:

• General criteria：

1. Severe renal insufficiency, hepatic dysfunction (Cr \> 2 times normal limit or renal dialysis, ALT or AST \> 5 times normal limit).
2. Major amputation before index procedure or plan for major amputation.
3. Any coagulation disorder.
4. Lower extremity arteries surgery or thrombolytic therapy in the ipsilateral extremity in the past 6 weeks.
5. Stroke within 3 months, or stroke with severe hemiplegia and aphasia sequelae more than 3 months before inclusion in the study.
6. Acute myocardial infarction or acute ischemia within 30 days before inclusion in the study.
7. Thromboangiitis obliterans (Buerger's disease).
8. Any previous treatment with drug eluting balloon or drug eluting stent within 90 days before inclusion.
9. Any surgery in target vessel before index procedure.
10. Volume reduction operation in target vessel before inclusion.
11. 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.
12. Subject with a history of iron overload or iron disorders related diseases, such as hereditary hemochromatosis, etc.
13. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
14. Women of child-bearing potential not using an effective contraception; pregnant or lactating women.
15. Subject is not suitable to participate in the trial as per investigators discretion.
16. Life expectancy ≤ 12 months as per investigators judgement.

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

Where this trial is running

Florence

• Azienda Ospedaliero Universitaria Careggi — Florence, Italy (Recruiting)

Study contacts

• Study coordinator: Ying Xia

Conditions Infrapopliteal Lesions; Critical Limb Ischemia; BTK; below-the-knee; Infrapopliteal lesions