Actively Recruiting
IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial
Led by Biotyx Medical (Shenzhen) Co., Ltd. · Updated on 2023-08-02
100
Participants Needed
1
Research Sites
154 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
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.
CONDITIONS
Official Title
IBS Titan™ Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 85 years
- Ability to understand the trial purpose, voluntarily participate, sign informed consent, and commit to 12-month follow-up
- Symptomatic Critical Limb Ischemia, Rutherford category 3-5
- Need for primary treatment of new infrapopliteal lesions
- Target lesion stenosis 70% or more or occlusion in no more than two infrapopliteal arteries
- Lesions located at least 10 cm above the ankle mortise
- Lesion in proximal two-thirds of native infrapopliteal vessels, length 200 mm or less, vessel diameter 2.5-4 mm
- Treatment limited to two infrapopliteal vessels at the same time
- Maximum of two stents per target vessel
- At least one unimpaired artery with less than 30% stenosis to the ankle
You will not qualify if you...
- Severe kidney or liver dysfunction (creatinine over twice normal, dialysis, or ALT/AST over 5 times normal)
- Major amputation before or planned before procedure
- Any coagulation disorder
- Lower extremity artery surgery or thrombolytic therapy in same leg within past 6 weeks
- Stroke within past 3 months or stroke with severe lasting effects more than 3 months ago
- Heart attack or acute ischemia within 30 days before study
- Thromboangiitis obliterans (Buerger's disease)
- Previous drug eluting balloon or stent treatment within 90 days
- Surgery or volume reduction operation on target vessel before 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
- Participation in another ongoing clinical trial
- Women of child-bearing potential not using effective contraception, pregnant or breastfeeding
- Investigator judgment deeming participant unsuitable or life expectancy 12 months or less
- Significant narrowing or occlusion in inflow arteries (iliac, femoral, popliteal)
- Significant narrowing of outflow arteries perfused by target vessel
- In-stent restenosis in any lower limb artery
- Thrombosis in target vessel or needing thrombolysis/thrombectomy
- Guide wire cannot pass target lesion
- Need for specific surgeries or therapies during procedure
- Aneurysm in lower limb arteries on the same leg
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Actively Recruiting
Research Team
Y
Ying Xia
CONTACT
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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