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)

Acotec Scientific Co., Ltd1 site in 1 country164 target enrollmentFebruary 20, 2023

ConditionsStenosis of Native Hemodialysis Arteriovenous Fistulas

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Stenosis of Native Hemodialysis Arteriovenous Fistulas
Sponsor: Acotec Scientific Co., Ltd
Enrollment: 164
Locations: 1
Primary Endpoint: Target Lesion Primary Patency Rate
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

February 20, 2023

End Date

June 2027

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Acotec Scientific Co., Ltd

Responsible Party

Sponsor

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

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