ACOART AVF RENEW: A Post Market Clinical Study

NCT06205576 | Recruiting

• 1 other identifier: ACOART AVF RENEW
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Stenosis of Native Hemodialysis Arteriovenous Fistulas

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Target Lesion Primary Patency Rate

  12 months，24 months

• All-cause mortality Rate

  24 months

Study Arms (1)

DCB catheter

EXPERIMENTAL

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

Interventions

DCB catheter DEVICE

Trade name of DCB catheter：Acoart Orchid＆Dhalia

DCB catheter

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acotec Scientific Co., Ltd: lead

Study Sites (1)

Beijing Haidian Hospital

Beijing, China

RECRUITING

Central Study Contacts

Wang Yu Zhu

CONTACT

010-82693657; wangyuzhu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 16, 2024
• Study Start: February 20, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2027
• Last Updated: January 16, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)