Chronic Limb-Threatening IschemiaNCT06330493
AcoArt Litos PCB Below-the-knee Global Trial
A study testing PCB and PTA in people with Chronic Limb-Threatening Ischemia, run by Acotec Scientific Co., Ltd at 18 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Limb-Threatening Ischemia
- What is being tested?
- PCB and PTA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 10 Oct 2025to 24 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General Inclusion Criteria
- Age ≥ 18 years at the time of consent;
- Subjects 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 Commitee(EC) approved consent form;
- Female subjects 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 subjects will be exempted from this requirement in case they are sterile, infertile, or have been post-menopausal for at least 12 months (no menses);
- 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;
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- In case of Rutherford category 5: Subjects 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 Inclusion Criteria
- 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 joint(arteries of the foot). The treatment(investigational device or PTA, including pre-dilatation) may not extend beyond these indicated regions for more than 1cm;
- 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 indirect run-off to the foot;
- 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 maximum residual restenosis of ≤30% per visual assessment. If an inflow lesion must be treated within or proximal to the P3 segment of the popliteal artery, there must be a minimum of 3 cm healthy vascular segment between this(treated) lesion and the infrapopliteal target lesion;
- 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 dissection). Target lesion is not considered non-dilatable by the operator due to concentric, circumferential calcium and target lesion can be treated successfully by balloon angioplasty without the need for bail-out stenting.
Who cannot join
- 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 accepted.
- 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 extremity wound on the target limb(only WIfI infection grade 0-2 allowed);
- Subjects with infection grade 3 and ischemia grade 0 and 1 according to WIfI classification;
- Subjects not independently ambulating.
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- Subjects with neurotrophic ulcers, heel pressure ulcers or calcaneal ulcers with a risk for major amputation; Subjects with uncomplicated ulcers can be included;
- Subjects with documented active osteomyelitis, excluding the phalanges, that is beyond cortical involvement of the bone per clinical judgement;
- Subjects with vasculitis, systemic Lupus Erythematosus or polymyalgia rheumatica on active treatment;
- Subjects 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 pre-treated prior to the index procedure;
- Subjects currently enrolled in another investigational device, drug, or biological trial;
- Femal subjects 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, etc.) that would preclude compliance with the study protocol or currently receiving immune-suppressive, chemotherapeutic, or radiation therapy;
- 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 per standard of care;
- 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.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States16 sites
South Charlotte General & Vascular Surgery
Charlotte, North Carolina, 28278
Cleveland Clinic
Cleveland, Ohio, 44195-0001
John Muir Health
Concord, California, 94520
Clements University Hospital (UTSW)
Dallas, Texas, 75390
Sunrise Vascular
Danville, Virginia, 24541
Baylor Scott & White Research Institute (BSW)
Fort Worth, Texas, 76104
California Cardiovascular Consultants and Medical Associates
Fremont, California, 94545
Miami Vascular Center
Hialeah, Florida, 33012
First Coast Cardiovascular Institute
Jacksonville, Florida, 32255
Ballad Health CVA Heart Institute
Kingsport, Tennessee, 37660
North Dallas Research Associates (NDRA)
McKinney, Texas, 75069
Yale School of Medicine
New Haven, Connecticut, 06519
Columbia University/NYPH
New York, New York, 10032
Cornell University
New York, New York, 10065
American Endovascular and Amputation Prevention (AEAP)
Orange, New Jersey, 92868
Miriam Hospital
Providence, Rhode Island, 02906
About this study
Official title: Prospective Multi-Center Randomized Controlled Trial to Evaluate the Safety and Efficacy of AcoArt Litos Paclitaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Versus Non-Coated Standard Balloon Angioplasty for the Treatment of Infrapopliteal Obstructions in Patients With Chronic Limb-Threatening Ischemia
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)
- Conditions
- Chronic Limb-Threatening Ischemia
- Being tested
- PCB, PTA
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCBDevice
Also called AcoArt Litos PCB
Paclitaxel coated PTA balloon catheter
PTADevice
Non-coated FDA cleared (US) or CE-marked (EU) standard percutaneous transluminal angioplasty balloon catheter
| Study group | Role | What they receive |
|---|---|---|
| PCB Group | Experimental | use PCB catheter(trade name: AcoArt Litos) to treat the stenosis or occlusion in infrapopliteal artery of experimental arm Receives: Device: PCB |
| PTA Group | Active comparator | use standard PTA balloon catheter to treat stenosis or occlusion in infrapopliteal artery of control group Receives: Device: PTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint: Composite of freedom from major amputation and primary patency
Composite of freedom from major amputation (above ankle amputation) and primary patency at 12 months. Primary patency is defined as absence of target lesion occlusion (no flow) and/or target lesion binary restenosis as determined by duplex ultrasound or angiography and/or clinically driven target lesion revascularization (CD-TLR).
Binary restenosis is defined as the presence of target lesion with a hemodynamically significant restenosis ≥ 50% by angiography or PSVR ≥ 2.4 by duplex ultrasound.
CD-TLR is defined as revascularization due to restenosis of ≥ 70% in the target lesion and
- Wound persistence and/or;
- Increase in size of pre-existing wounds and/or;
- Occurrence of new wounds and/or;
- Deterioration of Rutherford Class;
- Hemodynamic change: decrease in TBI of 0.15 or more.
Measured: 12 months
Primary Safety Endpoint: Composite of MALE and POD (Major Adverse Limb Event + Peri-Operative Death)
Major adverse limb event (MALE, defined as the composite of above-ankle amputation or major reintervention (new bypass graft, jump/interposition graft revision, or thrombectomy/thrombolysis) of the index limb involving a below-the-knee artery) and perioperative death (POD) at 30 days.
Measured: 30 days
Secondary outcomes (20)
Powered Secondary Endpoint: Freedom from clinically driven TLR (CD-TLR) at 12 months
CD-TLR is defined as revascularization due to restenosis of ≥ 70% in the target lesion and
- Wound persistence and/or;
- Increase in size of pre-existing wounds and/or;
- Occurrence of new wounds and/or;
- Deterioration of Rutherford Class;
- Hemodynamic change: decrease in TBI of 0.15 or more.
Measured: 12 months
Composite of Limb salvage and primary patency
Composite of limb salvage and primary patency at 1, 3, 12, 24 and 36 months
Measured: 1, 3, 12, 24 and 36 months
Patency rate
Patency rate is defined as the absence of target lesion occlusion(flow/no flow) as determined by duplex ultrasound and/or angiography and freedom from clinically-driven TLR;
Measured: 1, 3, 6, 12, 24, 36 months
Freedom from CD-TLR
CD-TLR is defined as revascularization due to restenosis of ≥ 70 % in the target lesion and
- Wound persistence and/or;
- Increase in size of pre-existing wounds and/or;
- Occurrence of new wounds and/or;
- Deterioration of Rutherford Class;
- Hemodynamic change: decrease in TBI of 0.15 or more.
Measured: 1, 3, 6, 12, 24, 36 months
Re-occlusion rate of target lesion
Re-occlusion rate of target lesion as determined by duplex ultrasound(no flow) and/or angiography;
Measured: 1, 3, 6, 12, 24, 36 months
Rate of Major adverse events(MAE)
MAE is defined as all-cause death, target limb major amputation and CD-TLR;
Measured: 1, 3, 6, 12, 24, 36 months
Rate of target limb major amputation
Rate of target lmb major amputations at 1, 3, 6, 12, 24, 36, 48 and 60 months;
Measured: 1, 3, 6, 12, 24, 36, 48, 60 months
Rate of all-cause death
Rate of all-cause death at 1, 3, 6, 12, 24, 36, 48 and 60 months;
Measured: 1, 3, 6, 12, 24, 36, 48, 60 months
Amputation free survival rate
Amputation free survival rate at 1, 3, 6, 12, 24, 36, 48 and 60 months;
Measured: 1, 3, 6, 12, 24, 36, 48, 60 months
Change in ankle-brachial index(ABI)
Change in ABI from pre-procedure to 1, 3, 6, 12, 24 and 36 months
Measured: 1, 3, 6, 12, 24, 36 months
Change in toe-brachial index(TBI)
Change in TBI from pre-procedure to 1, 3, 6, 12 and 24 months
Measured: 1, 3, 6, 12, 24 months
Change in Rutherford category
Change in Rutherford category from pre-procedure to 1, 3, 6, 12, 24 and 36 months
Measured: 1, 3, 6, 12, 24 and 36 months
Change in EQ-5D
Change in EQ-5D from pre-procedure to 1,3, 6,12, 24 and 36 months
Measured: 1, 3, 6, 12, 24 and 36 months
Change in VascuQol
Change in VascuQol from pre-procedure to 1,3, 6,12, 24 and 36 months
Measured: 1, 3, 6, 12, 24 and 36 months
Primary sustained clinical improvement
An improvement shift in the Rutherford classification of 1 class in amputation-free, clinically driven TLR-free surviving patients at 1 year
Measured: 1 year
Secondary sustained clinical improvement
An improvement shift in the Rutherford classification of 1 class including the need for clinically driven TLR in amputation-free surviving patients at 1 year
Measured: 1 year
Wound healing
The wound will be evaluated at 1, 3, 6, 12, 24 and 36months
Measured: 1, 3, 6, 12, 24 and 36 months
Rate of Device Success
Device Success is defined as, a per device basis, the achievement of successful delivery and deployment of the study device(s) at the intended target lesion, without balloon rupture or inflation/deflation abnormalities and a successful withdrawal of the delivery catheter
Measured: During the procedure(After using the PCB catheter)
Rate of Technical Success
Technical Success is defined as successful vascular access and completion of the endovascular procedure and immediate morphological success with ≤ 50% residual diameter stenosis in the treated lesion on completion angiography
Measured: During the procedure(After using the PCB catheter)
Rate of Procedure Success
Evidence of both acute technical success and absence of safety events(e.g., death, stroke, myocardial infraction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and/or need for urgent/emergent vascular surgery) within 72 hours of the index procedure
Measured: within 72 hours of the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start10 Oct 2025
- Primary completion24 Aug 2026
- Study completion24 Aug 2026
Why it stopped: Terminated based on a corporate strategic decision regarding portfolio prioritization. The termination is not due to any identified safety signals, device performance concern, or change in the benefit-risk assessment of the AcoArt Litos PCB Catheter.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Limb-Threatening IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acotec Scientific Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Schneider, MD, PhD, Principal investigator, University of California, San FranciscoSahil Parikh, MD, PhD, Principal investigator, Columbia UniversityThomas Zeller, MD, PhD, Principal investigator, University of Herzzentrum Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06330493
- Sponsor's protocol ID
- AcoArt BTK Global Trial
- Status last verified
- Aug 2026
- First submitted
- 10 Mar 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided