Actively Recruiting
Prospective Multicentre Trial to Assess Safety and Effectiveness of Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan17) in Patients With Infrapopliteal Arterial Stenosis or Occlusive Disease
Led by Biotyx Medical (Shenzhen) Co., Ltd. · Updated on 2023-08-02
100
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
B
Biotyx Medical (Shenzhen) Co., Ltd.
Lead Sponsor
V
VascuScience GmbH
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan17) in treating patients with infrapopliteal arterial stenosis or occlusive disease. This prospective, multicenter, single-arm clinical trial will include 100 participants who have symptomatic Critical Limb Ischemia with Rutherford category 3-5 and require primary treatment of de novo infrapopliteal lesions. Participants will be treated using the IBS Titan17 device, which is implanted to support affected arteries. The study will follow patients at 1 month, 6 months, and 12 months after hospital discharge to monitor treatment outcomes. The trial involves only one treatment group where all subjects receive the IBS Titan17 scaffold. During the study, researchers will assess outcomes such as freedom from primary efficacy failure at 6 months, major adverse events at 1, 6, and 12 months, and success rates immediately after the procedure. They will also measure changes in ankle-brachial index and Rutherford category compared to before treatment to evaluate improvement. Follow-up visits include various evaluations lasting up to one year after treatment.
CONDITIONS
Brief Title
IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 85 years old
- Able to understand the trial purpose and give informed consent
- Willing to participate until 12 months follow-up
- Have symptomatic Critical Limb Ischemia, Rutherford category 3-5
- Require primary treatment of new infrapopliteal lesions
- Target lesion with 70% stenosis or occlusion in no more than two infrapopliteal arteries
- Lesion located at least 10 cm above the ankle mortise
- Lesion in proximal two-thirds of native infrapopliteal vessels, length 200 mm, vessel diameter 2.5-4 mm
- Only two infrapopliteal vessels treated at the same time
- Maximum of two stents allowed in one target vessel
- At least one unimpaired artery to the ankle (less than 30% stenosis)
You will not qualify if you...
- Severe kidney or liver dysfunction (creatinine > 2 times normal, dialysis, ALT or AST > 5 times normal)
- Major amputation before or planned
- Any blood clotting disorder
- Recent lower extremity artery surgery or thrombolytic therapy in the same leg within 6 weeks
- Stroke within 3 months or severe lasting stroke symptoms over 3 months
- Acute heart attack or ischemia within 30 days
- Buerger's disease (thromboangiitis obliterans)
- Drug-eluting balloon or stent treatment within 90 days
- Surgery or volume reduction operation in the target vessel before the procedure
- Allergies to aspirin, heparin, clopidogrel, polylactic acid, iron, zinc, contrast agents, sirolimus, or inability to tolerate dual anti-platelet therapy
- History of iron overload or related diseases
- Currently in another clinical trial without completed primary endpoint
- Women of child-bearing potential not using effective contraception; pregnant or breastfeeding
- Investigator judgment unsuitability or life expectancy less than 12 months
- Significant stenosis or occlusion in inflow or outflow arteries
- In-stent restenosis or thrombosis in lower extremity arteries
- Guide wire cannot pass lesion or need for additional complex procedures
- Aneurysm in lower extremity artery on the same leg as treatment
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure with immediate post-procedure assessments
Participants receive treatment with the Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™) to address infrapopliteal arterial stenosis or occlusive disease.
1 visit (in-person) for the procedure and immediate evaluations
Duration - 12 months
Participants are monitored for safety and effectiveness of the treatment through assessments of adverse events, device success, and clinical changes.
Visits at 1 month, 6 months, and 12 months
Trial Site Locations
Total: 1 location
1
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Actively Recruiting
Research Team
Y
Ying Xia
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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