Actively Recruiting
A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon in Treating Below-the-knee Artery Lesions
Led by Acotec Scientific Co., Ltd · Updated on 2024-08-01
107
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the Acotec Litos & Tulip Drug-coated Balloon (DEB) catheters for treating lesions in below-the-knee arteries in people with Peripheral Artery Disease. This prospective, multi-center, single arm study aims to gather detailed data on how well this device works and its safety when used for this condition. Participants are adults aged 18 to 75 with specific artery blockage conditions affecting blood flow below the knee. Participants will receive treatment using the DEB catheter, either the AcoArt Tulip (0.018") or AcoArt Litos (0.014") model, to address stenosis or occlusions in below popliteal arteries. This single arm study means all participants receive the study device without comparison groups. The treatment targets significant artery narrowing or blockages to improve blood flow. The study does not mention placebo or alternative treatments. During the study, participants will be monitored through regular follow-up visits to evaluate the primary outcome of artery patency at 6 months. Secondary outcomes include major adverse event rate at 30 days, patency rates up to 60 months, rates of major limb amputation, mortality, vessel and lesion revascularization, ulcer healing, and distal embolization rates. Participants will undergo examinations and assessments specified by the protocol to track their response to the treatment and safety over time. The study is expected to continue until April 2027.
CONDITIONS
Brief Title
ACOART BTK RENEW：A Post Market Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and up to 75 years old
- Rutherford clinical category classification of 3, 4, or 5
- Significant stenosis (70% or more) or occlusions of new or restenotic lesions located in below-the-knee arteries with patent distal blood flow
- Reference vessel diameter between 2 mm and 4 mm
- Written informed consent provided and agreement to comply with all study examinations and follow-up appointments
You will not qualify if you...
- Plasma creatinine clearance rate below 30 mL/min
- Acute vessel occlusion or thrombosis in the target lesion
- Planned amputation on the target limb
- Completely non-ambulatory and confined to bed
- Thrombolytic therapy or surgery on the target limb within 6 weeks before enrollment
- Life expectancy less than 5 years
- Total length of fully occluded target lesions greater than 150 mm
- In-stent restenosis within the target lesion or target lesion within 20 mm of a stent
- History of stroke within 90 days before enrollment
- Known allergy to contrast agents, antiplatelet, anticoagulant, or thrombolytic therapy
- Uncorrectable bleeding disorders
- Inflow pathway lesion cannot be identified due to complete occlusion of the P3 segment of the popliteal artery
- Pregnant or breastfeeding female
- Unable to cross a guidewire through the target lesion
- Participation in other clinical trials of medical devices or drugs during the study period
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 - Single treatment session
Participants receive treatment using the DEB catheter to address stenosis or occlusion in the below-the-knee arteries.
1 treatment visit (in-person)
Duration - Up to 60 months
Participants are monitored for safety and efficacy outcomes including patency and adverse events.
Multiple follow-up visits up to 60 months
Trial Site Locations
Total: 1 location
1
Chui Yang Liu Hospital affiliated to Tsinghua University
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
Z
Zhuang Baixi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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