Actively Recruiting
ACOART AVF RENEW: A Post Market Clinical Study
Led by Acotec Scientific Co., Ltd · Updated on 2024-01-16
164
Participants Needed
1
Research Sites
223 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 Orchid＆Dhalia Drug-coated Balloon catheters for the treatment of for the obstructive lesions in the native Arteriovenous Dialysis Fistulae (AVF).
CONDITIONS
Official Title
ACOART AVF RENEW: A Post Market Clinical Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is 18 and 85 years of age
- The target AV fistula has undergone successful dialysis at least once
- Patient has a de novo and/or non-stented restenotic lesion located in the outflow vein (arteries and central vein excluded)
- Patient has a de novo and/or non-stented restenotic lesion (5% stenosis) with at least one of the following: abnormal physical exam, significant increase in venous pressure, or significant blood flow decrease
- Target lesion or tandem lesion is 4 100 mm in length
- Patient underwent successful crossing of the target lesion with guide wire and pre-dilatation with PTA balloon showing residual stenosis 4 30% and no severe dissection (Grade 3 or above) or perforation
- Patient provides written informed consent prior to enrollment
You will not qualify if you...
- Women who are breastfeeding, pregnant, or intending to become pregnant, or men intending to father children
- Dialysis access located in the lower extremity
- More than one lesion present
- Hemodynamically significant central venous stenoses
- Presence of a stent in the target AV access circuit
- Prior intervention of access site within 30 days before procedure
- Target AVF or access circuit with prior, current, or planned surgery
- Unable to receive recommended antiplatelet and/or anticoagulant therapy
- Undergoing immunotherapy or suspected/confirmed vasculitis
- History of coagulation dysfunction, thrombocytopenic purpura, or RH-negative blood type
- Infected AV access or systemic infection
- Life expectancy less than 24 months
- Anticipating kidney transplant or conversion to peritoneal dialysis
- Co-morbid condition that may cause non-compliance or confound data
- Currently enrolled in another investigational study and not completed primary endpoint, or previously enrolled in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Haidian Hospital
Beijing, China
Actively Recruiting
Research Team
W
Wang Yu Zhu
CONTACT
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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