Status:
RECRUITING
ACOART AVF RENEW: A Post Market Clinical Study
Lead Sponsor:
Acotec Scientific Co., Ltd
Conditions:
Stenosis of Native Hemodialysis Arteriovenous Fistulas
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
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 f...
Eligibility Criteria
Inclusion
- Patient is ≥18 and ≤85 years of age
- The target AV fistula has undergone successful dialysis for at least 1 time
- Patient has a de novo and/or non-stented restenotic lesion located in the outflow vein（Arteries and Central Vein are excluded）
- Patient has a de novo and/or non-stented restenotic lesion（≥50% stenosis）and at least one of the following occurs：
- The physical examination was abnormal
- Significant increase in dynamic venous pressure
- Blood flow decreased significantly
- Patient has a target lesion or a tandem lesion that is ≤ 100 mm in length
- Patient underwent successful crossing of the target lesion with the guide wire and pre-dilatation with a PTA balloon defined as:
- Residual stenosis of ≤ 30% AND
- Absence of a flow limiting dissection (Grade ≥C) or perforation
- Patient provides written informed consent prior to enrollment in the study
Exclusion
- Women who are breastfeeding, pregnant, or are intending to become pregnant, or men intending to father children
- Dialysis access is located in the lower extremity
- More than one lesion
- Patient with hemodynamically significant central venous stenoses
- Patient has presence of a stent located in the target AV access circuit
- Patient has undergone prior intervention of access site within 30 days of index procedure
- Patient with target AVF or access circuit which previously had or currently has a plan to surgery
- Patient who cannot receive recommended antiplatelet and/or anticoagulant therapy
- Patients undergoing immunotherapy or suspected/confirmed vasculitis
- Patients with a history of coagulation dysfunction, thrombocytopenic purpura or RH-negative blood type
- Patient has an infected AV access or systemic infection
- Patient has a life expectancy of \<24 months
- Patient is anticipating a kidney transplant or with anticipated conversion to peritoneal dialysis
- Patient has a co-morbid condition that, in the judgment of the Investigator, may cause him/her to be non-compliant with the protocol or confound the data interpretation
- Patient is enrolled in another investigational drug, device, or biologic study and has not completed the primary endpoint, or was previously enrolled in this study
Key Trial Info
Start Date :
February 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT06205576
Start Date
February 20 2023
End Date
June 1 2027
Last Update
January 16 2024
Active Locations (1)
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1
Beijing Haidian Hospital
Beijing, China