Actively Recruiting
ACOART BTK RENEW：A Post Market Clinical Study
Led by Acotec Scientific Co., Ltd · Updated on 2024-08-01
107
Participants Needed
1
Research Sites
273 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the Acotec Litos\&Tulip Drug-coated Balloon catheters in the treatment of lesions in below-the-knee artery.
CONDITIONS
Official Title
ACOART BTK RENEW：A Post Market Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older but not more than 75 years old
- Rutherford clinical category classification: 3, 4, or 5
- Significant stenosis (70% or more) or occlusions of new or restenotic lesions in below-the-knee arteries with open distal blood flow
- Reference vessel diameter between 2 mm and 4 mm
- Provided written informed consent and agrees to follow all study examinations and appointments
You will not qualify if you...
- Plasma creatinine clearance rate below 30 mL/min
- Acute vessel occlusion or acute 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 100% occluded target lesions more than 150 mm
- In-stent restenosis within target lesion or less than 20 mm distance between lesion and stent
- History of stroke within 90 days before enrollment
- Known allergy to contrast agents, antiplatelet, anticoagulant, or thrombolytic therapy
- Uncorrectable bleeding disorder
- Lesion in the inflow pathway cannot be identified due to complete occlusion of the P3 segment of the popliteal artery
- Pregnant or breastfeeding females
- Inability to cross a guidewire through the target lesion
- Participation in other clinical trials of medical devices or drugs during the same period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here