ACOART AVF RENEW: A Post Market Clinical Study

NCT ID: NCT06205576

Last Updated: 2024-01-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 164 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2027-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

DCB catheter

Intervention Type: DEVICE

Trade name of DCB catheter：Acoart Orchid＆Dhalia

Interventions

DCB catheter

Trade name of DCB catheter：Acoart Orchid＆Dhalia

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acotec Scientific Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Haidian Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Wang Yu Zhu

Role: CONTACT

wangyuzhu@163.com

010-82693657

Facility Contacts

Zhang Li Hong

Role: primary

Other Identifiers

ACOART AVF RENEW

Identifier Type: -

Identifier Source: org_study_id