Actively Recruiting
AcoArt Litos PCB Below-the-knee Global Trial
Led by Acotec Scientific Co., Ltd · Updated on 2025-07-03
288
Participants Needed
10
Research Sites
416 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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
- Willingness to comply with all follow-up evaluations and to sign informed consent
- Female participants of childbearing potential must have a negative pregnancy test within 7 days before procedure and agree to use reliable birth control, unless sterile, infertile, or post-menopausal for at least 12 months
- Life expectancy greater than 1 year as judged by the investigator
- Documented chronic limb-threatening ischemia in the target limb classified as Rutherford category 4 or 5
- For Rutherford category 5: documented wound score 0-1, infection grade 0-2, and ischemia grade 2-3 according to WIfI classification
- No surgical or vascular interventions within 2 weeks before or planned within 30 days after the study treatment
- Reference vessel diameter between 2.0 and 4.0 mm suitable for device sizing
- Target lesion length 190 mm or less including stenosis or occlusion
- Lesion located in infrapopliteal arteries above the ankle joint, not extending beyond 1 cm proximal to P3 segment of popliteal artery or below tibiotalar joint
- Presence of documented blood flow to the foot via at least one runoff vessel seen on angiography
- No flow-limiting (50% or more) inflow lesions unless treated successfully before enrollment with less than 30% residual stenosis
- Successful pre-dilatation of the entire target lesion with 50% or less residual stenosis and no flow-limiting dissection below Grade D
- Target lesion treatable by balloon angioplasty without need for stenting
You will not qualify if you...
- Planned major amputation above the metatarsal level or major surgery within 30 days before or after procedure
- Recent heart attack or stroke within 30 days before procedure
- Active infection at time of procedure, except controlled localized lower extremity wound infection (WIfI infection grade 0-2)
- Infection grade 3 with ischemia grade 0 or 1 according to WIfI classification
- Unable to walk independently
- Neurotrophic, heel pressure, or calcaneal ulcers with high risk for major amputation; uncomplicated ulcers allowed
- Active osteomyelitis beyond cortical bone involvement except in phalanges
- Active treatment for vasculitis, systemic lupus erythematosus, or polymyalgia rheumatica
- Severe kidney impairment with eGFR less than 30 ml/min or dialysis
- Systemic corticosteroid therapy exceeding 5 mg prednisolone daily during first 9 months after procedure
- Allergies to heparin, aspirin, other anticoagulants/anti-platelet therapies that cannot be substituted, paclitaxel, or contrast media unable to be pre-treated
- Currently enrolled in another investigational drug, device, or biological trial
- Breastfeeding females at enrollment
- Significant gastrointestinal bleeding or coagulopathy contraindicating anti-platelet therapy
- Severe medical conditions such as untreated coronary artery disease, class IV heart failure, low left ventricular ejection fraction (30% or less), severe COPD, metastatic cancer, or ongoing immunosuppressive, chemotherapy, or radiation treatments
- Occlusions extending distal to ankle joint space
- Untreated inflow lesions (50% or more stenosis) in ipsilateral iliac, superficial femoral artery, or popliteal arteries
- Failure to reduce inflow lesion stenosis to less than 30% after treatment
- Prior stents or bypass surgery in target vessels
- Drug-coated balloon procedures in target vessels within 6 months prior to study
- Aneurysm in target vessel
- Presence of thrombus in target limb
- Pre-dilatation causing major flow-limiting dissection (Grade D or higher) or residual stenosis over 50%
- Use of alternative therapies like atherectomy, scoring balloon, laser, radiation, or stents in target vessel treatment
AI-Screening
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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
CONTACT
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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