ACOART AVF RENEW: A Post Market Clinical Study (NCT06205576) | Clinical Trial Compass
RecruitingNot Applicable
ACOART AVF RENEW: A Post Market Clinical Study
China164 participantsStarted 2023-02-20
Plain-language 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).
Who can participate
Age range18 Years – 85 Years
SexALL
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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 antiplatel…