ACOART AVF RENEW: A Post Market Clinical Study

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)

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).

Study Overview

• Status: Recruiting
• Conditions: Stenosis of Native Hemodialysis Arteriovenous Fistulas
• Intervention / Treatment: Device: DCB catheter

• Study Type: Interventional
• Enrollment (Estimated): 164
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wang Yu Zhu; Phone Number: 010-82693657; Email: wangyuzhu@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Beijing Haidian Hospital
    • Contact: Zhang Li Hong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DCB catheter; 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.	Device: DCB catheter; Trade name of DCB catheter：Acoart Orchid＆Dhalia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Primary Patency Rate	Defined as freedom from clinically-driven target lesion revascularization (CD-TLR) or access circuit thrombosis measured.	6 months
Serious Adverse Event Rate	Defined as the Serious Adverse Event (SAE) rate involving the AV access circuit.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Primary Patency Rate	Defined as freedom from CD-TLR or access thrombosis occurring in the target lesion post-procedure.	12 months，24 months
All-cause mortality Rate	All-cause mortality post procedure	24 months

Collaborators and Investigators

• Sponsor: Acotec Scientific Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 4, 2024
• First Posted (Actual): January 16, 2024

Study Record Updates

• Last Update Posted (Actual): January 16, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: ACOART AVF RENEW

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No