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ACOART AVF RENEW: A Post Market Clinical Study

Study on AVF treatment outcomes after market approval.

Recruiting
18-85 years
All
Phase N/A

This study is looking into how well the Acotec Orchid™ Dhalia Drug-coated Balloon catheters work in patients with blocked blood vessels in their Arteriovenous Dialysis Fistulae (AVF). This is a special type of access used for dialysis, a treatment for kidney failure. The study will collect data from multiple centers and involve patients who meet certain criteria.

Key Points:

  • Participants must be between 18 to 85 years old and have had at least one successful dialysis using their AV fistula.
  • Participants should not have more than one lesion and must have lesions that are ≤ 100 mm long.
  • Women who are pregnant or breastfeeding, and men planning to father children, are excluded from the study.

Participants will need to provide written consent to join. This study aims to ensure that the device is safe and performs well for patients needing dialysis. It's important to note that some people, like those with certain medical conditions or more than one blockage, cannot join this study.

Study details
    Stenosis of Native Hemodialysis Arteriovenous Fistulas

NCT06205576

Acotec Scientific Co., Ltd

7 November 2025

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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