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New treatment option for Critical Limb Ischemia (CLI)
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
ClinicalTrials.gov ID: NCT07006467
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- General
- 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. Anatomical
You likely can't join if
- General exclusion criteria:
- Subject is currently participating in another clinical investigation that has not yet reached the primary endpoint.
- Pregnant or nursing people 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...
- Incapacitated individuals, as defined as persons who are mentally ill, mentally handicapped, or individuals without legal authority, are excluded...
- Subject has known hypersensitivity or contraindication to device material and its degradants (poly (L-lactide), poly (glycolic acid), lactic acid...
See the full eligibility criteria
Who can join
- General
- 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. Anatomical
- 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.
- 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
What rules you out
- General exclusion criteria:
- Subject is currently participating in another clinical investigation that has not yet reached the primary endpoint.
- Pregnant or nursing people 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...
- 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...
- 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...
- Subject with planned surgery or procedure necessitating discontinuation of antiplatelet medications, within 3 months after index procedure.
- Subject has life expectancy ≤ 1 year.
- Subject has had a stroke within the previous 3 months with residual Rankin score of ≥2.
- Subject has renal insufficiency as defined as an estimated GFR \< 30ml/min per 1.73m2
- Subject has platelet count \ 700,000 cells/mm3, a WBC \< 3,000 cells/mm3, or hemoglobin \< 9.0 g/dl.
- Subject has known serious immunosuppressive disease (e.g. human immunodeficiency virus), or has severe autoimmune disease, that requires chronic immunosuppressive therapy (e.g. systemic lupus erythematosus, etc.), or...
- Subject has Body Mass Index (BMI) \< 18.
- Subject has a known coagulation disorder with increased risk of arterial thrombosis. Subject with deep vein thrombosis and disorders that increase the risk of deep vein thrombosis can be included in the study.
- Subject who requires thrombolysis as a primary treatment modality or requires other treatment for acute limb ischemia of the target limb.
- Subject has previously had or requires surgical revascularization involving any vessel of the ipsilateral extremity.
- Subject has signs or symptoms of advanced limb infection or septicemia (fever \> 38.5 degrees Celsius, WBC \> 15,000 cells/microliter, hypotension) at the time of assessment.
- Subject with extensive tissue loss salvageable only with complex foot reconstruction or non-traditional transmetatarsal amputation. Anatomic exclusion criteria:
- Subject has tandem lesions at the target lesion site (plaque free zone \< 2 cm)
- Pre-dilatation of the target lesion at the time of study intervention did not reach \<50% residual diameter stenosis by angiography.
- Target lesion that has prior metallic stent implant.
- Failed PTA of target lesion ≤ 60 days prior to the procedure date.
- The target vessel has another significant lesion (≥50% diameter stenosis by angiography).
- Significant stenosis (≥50% stenosis) lesion in a distal outflow artery that would be perfused by the target vessel and that requires treatment at the time of the index procedure.
- Subject has angiographic evidence of, thrombus, thromboembolism or atheroembolism in the ipsilateral extremity.
- Unsuccessfully treated proximal inflow limiting arterial stenosis or inflow-limiting arterial lesions left untreated.
- Aneurysm in the iliac, common femoral, superficial femoral, popliteal or target artery of the ipsilateral extremity.
- Target lesion has a high probability that atherectomy will be required at the time of index procedure for treatment of the target vessel.
The study team makes the final eligibility decision.
Where it's taking place
- Graz, Austria
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Graz, Austria. 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.