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ACOART AVF RENEW: A Post Market Clinical Study

RecruitingNAAges 18 Years - 85 YearsAllAcotec Scientific Co., Ltd
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • DCB catheter
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Where

1 site
Beijing Haidian Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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