ACOART AVF RENEW: A Post Market Clinical Study

Acotec Scientific

Status: Enrolling

Conditions: Stenosis of Native Hemodialysis Arteriovenous Fistulas

Treatments: Device: DCB catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT06205576

ACOART AVF RENEW

Details and patient eligibility

About

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).

Enrollment: 164 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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164 participants in 1 patient group

DCB catheter

Experimental group

Description:

Using DCB catheter for the treatment of subjects with a de novo or non-stented restenotic obstructive lesion located in the native arteriovenous dialysis fistulae.

Treatment:

Device: DCB catheter