Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intend… (NCT07006467) | Clinical Trial Compass
RecruitingNot Applicable
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
Austria10 participantsStarted 2025-06-03
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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. Quantitative imaging (IVUS and angiography) will be used to aid accurate sizing of the vessels.
Exclusion criteria
✕
What they're measuring
1
Safety: Freedom from Major Adverse Limb Event (MALE) + Perioperative Death (POD)
Timeframe: 30 day follow-up
2
Performance: Number of patients with Technical Success
. 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, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements.
✕. Incapacitated individuals, as defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded from the study population.
✕. Subject has known hypersensitivity or contraindication to device material and its degradants (poly (L-lactide), poly (glycolic acid), lactic acid, and glycolic acid) that cannot be adequately pre-medicated. Subject has known contrast sensitivity that cannot be adequately pre-medicated.
✕. Subject has known allergy hypersensitivity or contraindication to aspirin; or to ADP antagonists such clopidogrel, prasugrel or ticagrelor; or to anticoagulants such as heparin or bivalirudin, and therefore cannot be adequately treated with study medications.
✕. Subject with planned surgery or procedure necessitating discontinuation of antiplatelet medications, within 3 months after index procedure.