Actively Recruiting
Prospective Multi-Center Randomized Controlled Trial to Evaluate the Safety and Efficacy of AcoArt Litos Paclitaxel Coated PTA Balloon Versus Standard Balloon Angioplasty for Treating Infrapopliteal Obstructions in Chronic Limb-Threatening Ischemia
Led by Acotec Scientific Co., Ltd · Updated on 2025-07-03
288
Participants Needed
10
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of the AcoArt Litos Paclitaxel Coated Percutaneous Transluminal Angioplasty (PTA) Balloon compared to a standard non-coated PTA balloon catheter. The study focuses on treating blockages in the infrapopliteal arteries, which are located below the knee and above the ankle, in patients with chronic limb-threatening ischemia (CLTI) classified as Rutherford category 4 or 5. The aim is to see if the AcoArt Litos device is better in efficacy and not worse in safety compared to the standard device. Participants are randomly assigned to one of two groups. One group receives treatment with the AcoArt Litos paclitaxel-coated PTA balloon catheter, while the other group receives treatment with a standard FDA-cleared or CE-marked non-coated PTA balloon catheter. The study includes detailed angiographic criteria for the target lesions and vessels. The procedure involves balloon angioplasty in the infrapopliteal arteries with pre-dilatation required before randomization. The trial includes follow-up visits at multiple time points up to five years to assess device success and patient outcomes. During the study, participants will undergo evaluations such as angiography, measurements of blood flow indexes like ankle-brachial and toe-brachial indexes, wound healing assessments, and quality of life questionnaires. Primary outcomes include freedom from major amputation and maintaining artery openness over 12 months, as well as safety endpoints within 30 days after the procedure. Secondary outcomes track limb salvage, re-intervention rates, adverse events, and survival over several years. Participants will be monitored regularly to assess clinical improvements and device performance throughout the study duration.
CONDITIONS
Brief Title
AcoArt Litos PCB Below-the-knee Global Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at the time of consent
- Willing and able to comply with all follow-up visits and sign approved consent
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before procedure and use reliable birth control during study (exceptions for sterile, infertile, or post-menopausal women)
- Life expectancy greater than 1 year as judged by investigator
- Documented chronic limb-threatening ischemia in target limb with Rutherford category 4 or 5
- For Rutherford category 5: wound score 0-1, infection grade 0-2, ischemia grade 2-3 per WIfI classification
- No prior surgical or vascular intervention within 2 weeks before and no planned intervention within 30 days after treatment
- Reference vessel diameter between 2.0 and 4.0 mm treatable by study device
- Target lesion length 190 mm or less with significant stenosis (70-99%) or occlusion
- Lesion located in infrapopliteal arteries above ankle and below P3 popliteal artery segment, treatment limited to these regions
- Presence of documented run-off to the foot with at least one visible vessel by angiography
- No flow-limiting (≥50%) inflow lesions unless treated with ≤30% residual stenosis and at least 3 cm healthy vessel between inflow lesion and target lesion
- Successful pre-dilatation of target lesion with ≤50% residual stenosis and no severe dissection (< Grade D)
You will not qualify if you...
- Planned amputation above metatarsal level or major surgery within 30 days before or after procedure
- Recent heart attack or stroke within 30 days before procedure
- Active systemic infection at procedure time, except controlled local wound infection with WIfI infection grade 0-2
- Infection grade 3 and ischemia grade 0 or 1 per WIfI
- Unable to walk independently
- Neurotrophic, heel pressure, or calcaneal ulcers with high amputation risk; uncomplicated ulcers allowed
- Active osteomyelitis beyond bone cortex, excluding phalanges
- Active treatment for vasculitis, lupus, or polymyalgia rheumatica
- Severe kidney impairment (eGFR <30 ml/min) or dialysis
- Systemic corticosteroid therapy over 5 mg prednisolone or equivalent daily during first 9 months
- Allergies to heparin, aspirin, anticoagulants that cannot be substituted, paclitaxel, or contrast media unmanageable by pre-treatment
- Participation in another investigational drug, device, or biological trial
- Breastfeeding female participants
- Significant bleeding disorders or coagulopathy contraindicating antiplatelet therapy
- Severe medical conditions precluding protocol compliance or receiving immune-suppressive, chemotherapy, or radiation therapy
- Occlusions extending below ankle joint
- Untreated inflow lesions ≥50% stenosis in ipsilateral iliac, SFA, or popliteal arteries
- Failure to reduce inflow lesion stenosis to ≤30% after treatment
- Prior stents or bypass surgery in target vessels
- Drug-coated balloon treatment in target vessels within 6 months
- Aneurysm in target vessel
- Angiographic thrombus in target limb
- Major flow-limiting dissection (≥ Grade D) or residual stenosis >50% after pre-dilatation
- Use of alternative therapies like atherectomy, scoring balloons, laser, radiation, or stents in target vessel
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day
Participants undergo a procedure using either the paclitaxel coated PTA balloon catheter or the standard PTA balloon catheter to treat stenosis or occlusion in infrapopliteal arteries.
1 procedure visit (in-person)
Duration - Up to 60 months
Participants are monitored with follow-up visits to assess safety, efficacy, wound healing, limb salvage, and device success over time.
Visits at 1, 3, 6, 12, 24, 36, 48, and 60 months (in-person)
Trial Site Locations
Total: 10 locations
1
Miami Vascular Center
Hialeah, Florida, United States, 33012
Actively Recruiting
2
First Coast Cardiovascular Institute
Jacksonville, Florida, United States, 32255
Actively Recruiting
3
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States, 52801
Actively Recruiting
4
Columbia University/NYPH
New York, New York, United States, 10032
Actively Recruiting
5
South Charlotte General & Vascular Surgery
Charlotte, North Carolina, United States, 28278
Actively Recruiting
6
Miriam Hospital
Providence, Rhode Island, United States, 02906
Suspended
7
Clements University Hospital (UTSW)
Dallas, Texas, United States, 75390
Actively Recruiting
8
Sunrise Vascular
Danville, Virginia, United States, 24541
Actively Recruiting
9
Medical University Graz
Graz, Austria, 8036
Actively Recruiting
10
AZ Sint Blasius Hospital
Dendermonde, Belgium
Actively Recruiting
Research Team
L
Lijuan Jenny Wang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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