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Recruiting NCT06205576

ACOART AVF RENEW: A Post Market Clinical Study

No phase Interventional Stenosis of Native Hemodialysis Arteriovenous Fistulas

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DCB catheter.
Who it may be relevant to
Registry conditions: Stenosis of Native Hemodialysis Arteriovenous Fistulas. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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).

Interventions

  • Device DCB catheter
    Trade name of DCB catheter：Acoart Orchid＆Dhalia

Primary outcome measures

  • Target Lesion Primary Patency Rate [Time frame: 6 months]
  • Serious Adverse Event Rate [Time frame: 30 days]
Secondary outcome measures (2)
  • Target Lesion Primary Patency Rate [Time frame: 12 months，24 months]
  • All-cause mortality Rate [Time frame: 24 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Beijing Haidian Hospital — Beijing

Identifiers

NCT: NCT06205576 · ACOART AVF RENEW

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗