RecruitingNot ApplicableNCT06205576

ACOART AVF RENEW: A Post Market Clinical Study

A Post Market Clinical Study to Evaluate the Safety and Efficacy of the Acotec Drug-coated Balloon for the Treatment of the Obstructive Lesions in the Native Arteriovenous Dialysis Fistuae(AVF)

Sponsor

Acotec Scientific Co., Ltd

Enrollment

164 participants

Start Date

Feb 20, 2023

Study Type

INTERVENTIONAL

Conditions

Stenosis of Native Hemodialysis Arteriovenous Fistulas

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).

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria12

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 Criteria15

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

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Interventions

DEVICEDCB catheter

Trade name of DCB catheter：Acoart Orchid＆Dhalia

Locations(1)

Beijing Haidian Hospital

Beijing, China

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NCT06205576