Actively Recruiting
Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery
Led by Stentit · Updated on 2025-07-09
10
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is the First-In-Human feasibility study of the RFS for below the knee lesions in subjects who experience critical limb ischemia due to the peripheral artery disease. The aim of this study is to investigate if the RFS can be implanted safely and with technical success. Up to 10 subjects will be treated with the RFS at one investigational site. Lesions within the inflow trajectory or side branches may be treated with institutions standard of care prior to treatment of the target lesion. This may include usage of POBA, BMS, DCB, or DES. The target lesion will be predilated with POBA. Device safety will be assessed throughout the clinical investigation, with primary safety endpoints defined as freedom from Major Adverse Limb Events (MALE) at 30 days follow-up. In addition, MALE at 3-, 6-, 12-, and 24- months follow-up, all adverse events, serious adverse events and all device deficiencies will be captured as secondary endpoints. Device performance will be based on technical success of the implantation defined as successful delivery and deployment with a residual area stenosis of ≤50% as determined on final perioperative IVUS. Primary patency at day of discharge, 30-days, 3-, 6-, 12-, and 24- months follow up will be captured as secondary performance endpoint and are based on duplex ultrasound for all timepoints and angiography and IVUS at 6-months follow-up.
CONDITIONS
Official Title
Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject must provide written informed consent prior to any clinical investigation related procedures.
- Subject is willing and able to comply with the study procedures, and follow-up schedule.
- Subject has Critical Limb Ischemia (CLI), Rutherford Becker Clinical Category 4 or 5.
- Subject must be at least 18 years of age.
- Target lesion located in the tibioperoneal trunk, or 2/3 proximal part of the anterior tibial artery, posterior tibial artery or peroneal artery.
- Only one target lesion per subject is included; other lesions can be treated per institution's standard of care.
- At least one infrapopliteal branch without an angiographic significant lesion (≥50% diameter stenosis by angiography).
- Vessel diameter of 3.0 mm to 3.4 mm.
- Target lesion length ≤ 18 mm.
- Target lesion of ≥70% diameter stenosis, per angiographic assessment at the time of the procedure.
- Target lesion is in an area that may be stented without blocking access to subject main branches, i.e., ≥2 mm distanced from any bifurcation.
- Successful antegrade crossing of the target lesion.
You will not qualify if you...
- Subject is currently participating in another clinical investigation that has not yet reached the primary endpoint.
- Pregnant or nursing subjects or with planned pregnancy during the clinical investigation follow-up period.
- Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that could limit participation or compliance.
- Incapacitated individuals, including those mentally ill, mentally handicapped, or without legal authority.
- Known hypersensitivity or contraindication to device materials or contrast that cannot be adequately pre-medicated.
- Known allergy or contraindication to aspirin, ADP antagonists (such as clopidogrel, prasugrel, ticagrelor), or anticoagulants (heparin or bivalirudin).
- Planned surgery or procedure requiring stopping antiplatelet medications within 3 months after the procedure.
- Life expectancy ≤ 1 year.
- Stroke within the previous 3 months with residual Rankin score of ≥2.
- Renal insufficiency with estimated GFR < 30 ml/min per 1.73 m².
- Abnormal blood counts: platelet count < 100,000 or > 700,000 cells/mm³, WBC < 3,000 cells/mm³, or hemoglobin < 9.0 g/dl.
- Known serious immunosuppressive disease or severe autoimmune disease requiring chronic immunosuppressive therapy; stable treated HIV patients with undetectable viral load are eligible.
- Body Mass Index (BMI) < 18.
- Known coagulation disorder with increased risk of arterial thrombosis (DVT and related disorders allowed).
- Requires thrombolysis or other treatment for acute limb ischemia of the target limb.
- Previous or planned surgical revascularization of any vessel in the same limb.
- Signs or symptoms of advanced limb infection or septicemia at assessment.
- Extensive tissue loss requiring complex foot reconstruction or non-traditional transmetatarsal amputation.
- Tandem lesions at the target site (plaque free zone < 2 cm).
- Pre-dilatation of target lesion did not reduce diameter stenosis below 50%.
- Target lesion has prior metallic stent implant.
- Failed PTA of target lesion within 60 days prior to procedure.
- Target vessel has another significant lesion (≥50% diameter stenosis).
- Significant stenosis (≥50%) in a distal outflow artery requiring treatment during the procedure.
- Angiographic evidence of thrombus, thromboembolism, or atheroembolism in the same limb.
- Unsuccessfully treated or untreated proximal inflow limiting arterial stenosis.
- Aneurysm in iliac, common femoral, superficial femoral, popliteal, or target artery in the same limb.
- High probability that atherectomy will be required during the treatment procedure.
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Trial Site Locations
Total: 1 location
1
Medical Universiteit Graz
Graz, Austria, A-8036
Actively Recruiting
Research Team
K
Kim van Noort, PhD
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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