ACOART AVF RENEW: A Post Market Clinical Study
- Conditions
- Stenosis of Native Hemodialysis Arteriovenous Fistulas
- Interventions
- Device: DCB catheter
- Registration Number
- NCT06205576
- Lead Sponsor
- Acotec Scientific Co., Ltd
- 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 for the obstructive lesions in the native Arteriovenous Dialysis Fistulae (AVF).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 164
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DCB catheter DCB catheter Using DCB catheter for the treatment of subjects with a de novo or non-stented restenotic obstructive lesion located in the native arteriovenous dialysis fistulae.
- Primary Outcome Measures
Name Time Method Target Lesion Primary Patency Rate 6 months Defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured.
Serious Adverse Event Rate 30 days Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit.
- Secondary Outcome Measures
Name Time Method All-cause mortality Rate 24 months All-cause mortality post procedure
Target Lesion Primary Patency Rate 12 months，24 months Defined as freedom from CD-TLR or access thrombosis occurring in the target lesion post-procedure.
Trial Locations
- Locations (1)
Beijing Haidian Hospital
🇨🇳Beijing, China