Evaluation of the Safety and Efficacy of the Peripheral Scoring Drug Balloon (Dissolve AV) in Treatment of Hemodialysis Arteriovenous Fistulae Stenosis A Prospective Multicenter Randomized Controlled Clinical Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Fistulas Arteriovenous
- Sponsor
- DK Medical Technology (Suzhou) Co., Ltd.
- Enrollment
- 220
- Locations
- 10
- Primary Endpoint
- Target lesion primary patency (TLPP) at 6 months post-procedure
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
Drug-coated balloons delivering paclitaxel at the angioplasty site have proved their superiority in the treatment of coronary and peripheral arterial stenoses. Paclitaxel reduces neointimal hyperplasia, therefore, it represents an attractive option for AVF stenoses. This trial is aimed to evaluate the safety and efficacy of Peripheral scoring drug balloon (Dissolve AV) or Balloon Dilatation catheter ( Armada 35) in treating AVF stenosis in chinese population.
Detailed Description
This is a prospective, multi-center, randomized controlled, open-label, superiority study. A total of 220 subjects will be enrolled from 11 sites in China. All subjects enrolled will be randomly assigned to the test group (Dissolve AV group, n=110) and the control group (Armada 35 group, n=110) with randomized allocation ratio of 1:1. Subjects in the test group and the control group will be treated with Peripheral scoring drug balloon or Balloon Dilatation catheter
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-75 years (inclusive), male or female;
- •Patients with mature AVF/AVG and at least one successful hemodialysis session;
- •Target lesion located in the AVF/AVG reflux vein (excluding the feeding artery and central vein);
- •With hemodynamically significant AVF/AVG stenosis and meeting two of the following conditions (A \& B) A. ≥ 50% stenosis of the target lesion as assessed by angiography B. Presence of at least one of the following (as defined in the NKF-K/DOQI guidelines) 1)Significantly elevated venous pressure during dialysis 2)Unexplained decrease in dialysis dose 3)Decrease in pump-controlled blood flow;
- •De novo or restenotic target lesion consisting of one or more tandem lesions, and with a visual reference vessel diameter of 4.0-8.0 mm and a total length ≤ 40 mm for the target lesion;
- •All non-target lesions must have \<50% stenosis without clinical indication for treatment.
- •Patients who have signed the informed consent form.
Exclusion Criteria
- •Patients who are participating in another clinical trial of a drug product or medical device;
- •Patients previously enrolled in this trial;
- •Women of childbearing age with a non-negative pregnancy test prior to surgical procedure, or lactating women;
- •Patients treated with major surgeries (e.g., open-heart surgery, cranial surgery) within 30 days prior to enrollment in the study;
- •Immature AVF/AVG (not subjected to dialysis; this vascular access has not been subjected to a single successful dialysis due to insufficient inner diameter that prevents successful puncture and results in inadequate blood flow);
- •Calcified lesions that are not expected to be dilated with a balloon;
- •AVF/AVG implanted with a stent;
- •AVF/AVG lesions previously treated with DCB;
- •Target lesions located at the venous anastomosis of AVF/AVG;
- •Impaired central venous reflux ;
Outcomes
Primary Outcomes
Target lesion primary patency (TLPP) at 6 months post-procedure
Time Frame: 6 month post-procedure
TLPP ends with postoperative target lesion (including 5 mm proximal and 5 mm distal to the target lesion) failure (TLF) or target lesion-associated vascular access thrombosis. TLF is defined as the presence of at least one clinical symptom of inadequate dialysis blood flow (as defined in the NKF-K/DOQI guidelines) due to stenosis of the target lesion (≥ 50% stenosis of the target lesion on imaging), including significantly elevated venous pressure during dialysis, abnormal physical examination findings, and a decrease in pump-controlled blood flow.
Secondary Outcomes
- Clinical success(0 - 5 days post-procedure)
- Procedural Success(0 day post-procedure)
- Target lesion primary patency (TLPP) at 12 months post-procedure(12 Month post-procedure)
- Device success(0 day post-procedure)