Health TrialsbyHealthPanel

ACOART AVF RENEW: A Post Market Clinical Study

ConditionStenosis of Native Hemodialysis Arteriovenous Fistulas
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorAcotec Scientific Co., Ltd

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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：

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • DCB catheter

    Device

    Trade name of DCB catheter：Acoart Orchid＆Dhalia

Treatment groups

164 Participants
are divided into 1 treatment group
Group A: DCB catheterExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Target Lesion Primary Patency Rate

Defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured.

Time frame
6 months
2

Serious Adverse Event Rate

Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit.

Time frame
30 days

Secondary outcomes

1

Target Lesion Primary Patency Rate

Defined as freedom from CD-TLR or access thrombosis occurring in the target lesion post-procedure.

Time frame
12 months，24 months
2

All-cause mortality Rate

All-cause mortality post procedure

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Acotec Scientific Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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