Clinical trial NCT06205576: ACOART AVF RENEW: A Post Market Clinical Study
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stenosis of Native Hemodialysis Arteriovenous Fistulas
Lead sponsor: Acotec Scientific Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-01-16
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Target Lesion Primary Patency Rate
timeFrame: 6 months
measure: Serious Adverse Event Rate
timeFrame: 30 days
Secondary outcomes:
measure: Target Lesion Primary Patency Rate
timeFrame: 12 months，24 months
measure: All-cause mortality Rate
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Haidian Hospital
Study officials:
References: