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New treatment option for Chronic Limb-Threatening Ischemia
Official title AcoArt Litos PCB Below-the-knee Global Trial
ClinicalTrials.gov ID: NCT06330493
What this study is testing
- What it's testing
- The objective of this study is to assess whether efficacy of the AcoArt Litos PCB is superior and whether safety of AcoArt Litos PCB is noninferior to the control device (FDA cleared PTA Balloon Catheter) regarding treatment of obstructions in the infrapopliteal arteries (located distal to the P3 segment of the popliteal artery and extending to the tibiotalar joint) in patients presenting with chronic limb-threatening ischemia (CLTI)(Rutherford 4-5)
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 1. Age ≥ 18 years at the time of consent;
- people has been informed of the nature of the study, is willing to comply with all required follow-up evaluations within the defined follow-up visit...
- Female people of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure and are willing to use a reliable method of...
- Life expectancy \> 1 year in the Investigator's opinion;
- Subject presenting with documented chronic limb-threatening ischemia(CLTI) in the target limb defined as Rutherford category 4 or 5;
You likely can't join if
- \- General Exclusion Criteria
- Planned index limb amputation above the metatarsal level, or any other planned major surgery within 30 days pre- or post-procedure. A planed...
- Recent MI or stroke \< 30 days prior to the index procedure;
- Known or suspected active infection at the time of the index procedure(abnormal white blood cell count, fever, sepsis, or positive blood culture)...
- people with infection grade 3 and ischemia grade 0 and 1 according to WIfI classification;
- people not independently ambulating.
See the full eligibility criteria
Who can join
- \- General 1. Age ≥ 18 years at the time of consent;
- people has been informed of the nature of the study, is willing to comply with all required follow-up evaluations within the defined follow-up visit windows and has signed an Institutional Review Board(IRB)/Ethics...
- Female people of childbearing potential have a negative pregnancy test ≤ 7 days before the procedure and are willing to use a reliable method of birth control for the duration of study participation. Female people will...
- Life expectancy \> 1 year in the Investigator's opinion;
- Subject presenting with documented chronic limb-threatening ischemia(CLTI) in the target limb defined as Rutherford category 4 or 5;
- In case of Rutherford category 5: people with documented wound score 0-1, infection grade 0-2 and ischemia grade 2-3 according to the wound ischemia foot infection (WIfI) classification;
- No other prior surgical or vascular interventions within 2 weeks before and/or planned 30 days after the protocol treatment.
- Angiographic 8. Reference Vessel Diameter(RVD) ≥2.0 and ≤ 4.0mm and able to be treated with available device size matrix;
- Total length of target lesion (including significant stenosis 70\~99% or occlusion) ≤ 190mm;
- The lesion must be located in the infrapopliteal arteries and above the ankle joint. Lesions may not extend proximal to the P3 segment of the popliteal artery indicated by the tibial plateau or below the tibiotalar...
- Presence of documented run-off to the foot(clearly visible at least one of the following run-off vessels; dorsalis pedis or pedal arch or plantar arteries by angiography). The target vessels should give direct or...
- Absence of flow-limiting(≥ 50% stenosis) in-flow lesions confirmed by angiography. Patients with flow-limiting inflow lesions can be included if the lesion(s) have been treated successfully before enrollment, with a...
- Successful pre-dilatation of the(entire) target lesion. Success being documented by angiographic visual estimate of ≤ 50% residual diameter stenosis of the target lesion and no flow limiting dissection(\< Grade D...
What rules you out
- \- General Exclusion Criteria
- Planned index limb amputation above the metatarsal level, or any other planned major surgery within 30 days pre- or post-procedure. A planed amputation including and below the metatarsal level(1 or multiple rays) is...
- Recent MI or stroke \< 30 days prior to the index procedure;
- Known or suspected active infection at the time of the index procedure(abnormal white blood cell count, fever, sepsis, or positive blood culture), with the exception of a localized, controlled infection of a lower...
- people with infection grade 3 and ischemia grade 0 and 1 according to WIfI classification;
- people not independently ambulating.
- people with neurotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk for major amputation; people with uncomplicated ulcers can be included;
- people with documented active osteomyelitis, excluding the phalanges, that is beyond cortical involvement of the bone per clinical judgement;
- people with vasculitis, systemic Lupus Erythematosus or polymyalgia rheumatica on active treatment;
- people with impaired renal function defined as eGFR \<30 ml/min or on dialysis;
- Patient receiving systemic corticosyeroid therapy(expected dosage exceeding 5 mg of prednisolone or equivalent, per day, during the initial 9 months after procedure);
- Known allergies or sensitivities to heparin, aspirin(ASA), other anticoagulant/anti-platelet therapies which could not be substitued, and/or paclitaxel or an allergy to contrast media that cannot be adequately...
- people currently enrolled in another investigational device, drug, or biological trial;
- Femal people who are breast feeding at the time of enrollment;
- Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy;
- Any severe medical comorbidities(e.g., untreated CAD/CHF, NYHA class IV heart failure, Left Ventricular ejection fraction(LVEF) \</= 30%(obtained within 1 month of index procedure), severe COPD, metastatic malignacy...
- Angiographic Exclusion Criteria
- Occlusions located or extending distal to the ankle joint space;
- Untreated (≥50% measured by angiography) inflow lesion or occlusion in the ipsilateral iliac, SFA nad popliteal arteries;
- Failure to obtain a ≤30% residual stenosis in pre-existing, hemodynamically significant(≥50% measured by angiography) in flow lesions in the ipsilateral iliac, SFA and popliteal artery. Inflow lesions should be treated...
- Prior stent(s) or bypass surgery within the target vessel(s) (including stents placed within target vessels during the index procedure prior to randomization);
- Previous procedure with drug-coated balloons in the target vessels within 6 months prior to index procedure.
- Aneurysm in the target vessel;
- Angiographic evidence of thrombus within target limb;
- Pre-dilatation resulted in a major(≥ Grade D) flow-limiting dissection(observed on 2 orthogonal views) or residual stenosis \>50%;
- Use of alternative therapy, e.g. atherectomy, scoring balloon, laser, radiation therapy, stents as part of target vessel treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Concord, California, United States
- Fremont, California, United States
- New Haven, Connecticut, United States
- Hialeah, Florida, United States
- Jacksonville, Florida, United States
- Davenport, Iowa, United States
- Orange, New Jersey, United States
- New York, New York, United States
- Charlotte, North Carolina, United States
- Cleveland, Ohio, United States
- Providence, Rhode Island, United States
- Kingsport, Tennessee, United States
- Dallas, Texas, United States
- Fort Worth, Texas, United States
- McKinney, Texas, United States
- Danville, Virginia, United States
- Graz, Austria
- Dendermonde, Belgium
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 Concord, California, United States; Fremont, California, United States; New Haven, Connecticut, United States; Hialeah, Florida, United States; Jacksonville, Florida, United States; Davenport, Iowa, United States and 12 more location(s). 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.