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New treatment option for Infrapopliteal Lesions
Official title IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial
ClinicalTrials.gov ID: NCT05971394
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
- Subject has symptomatic Critical Limb Ischemia, Rutherford category 3-5.
- Subject requires primary treatment of de novo infrapopliteal lesions.
You likely can't join if
- 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.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Florence, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Florence, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.