Clinical trial NCT04226599: A Safety and Efficacy Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With DissolveAV
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fistulas Arteriovenous
Keywords: Dialysis scoring Fistulas
Lead sponsor: DK Medical Technology (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-13
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

1. Age 18-75 years (inclusive), male or female;
2. Patients with mature AVF/AVG and at least one successful hemodialysis session;
3. Target lesion located in the AVF/AVG reflux vein (excluding the feeding artery and central vein);
4. 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;
5. 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;
6. All non-target lesions must have \<50% stenosis without clinical indication for treatment.
7. Patients who have signed the informed consent form.

Exclusion Criteria:

1. Patients who are participating in another clinical trial of a drug product or medical device;
2. Patients previously enrolled in this trial;
3. Women of childbearing age with a non-negative pregnancy test prior to surgical procedure, or lactating women;
4. Patients treated with major surgeries (e.g., open-heart surgery, cranial surgery) within 30 days prior to enrollment in the study;
5. 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);
6. Calcified lesions that are not expected to be dilated with a balloon;
7. AVF/AVG implanted with a stent;
8. AVF/AVG lesions previously treated with DCB;
9. Target lesions located at the venous anastomosis of AVF/AVG;
10. Impaired central venous reflux ;
11. Presence of a stenotic lesion in the artery that severely interferes with blood flow;
12. Patients with known allergy or intolerance to paclitaxel or contrast agent;
13. Patients with a life expectancy of less than 1 year;
14. Patients with concomitant systemic lupus erythematosus (SLE), ANCA-associated small vessel vasculitis;
15. Patients with a history of coagulopathy or thrombocytopenic purpura;
16. Patients treated with or scheduled to be treated with renal transplant or who have switched to peritoneal dialysis;
17. Vascular access infections or active systemic infections;
18. Presence of other medical conditions considered ineligible for the study as assessed by the investigator.

Primary outcomes:
measure: Target lesion primary patency (TLPP) at 6 months post-procedure
timeFrame: 6 month post-procedure
Secondary outcomes:
measure: Target lesion primary patency (TLPP) at 12 months post-procedure
timeFrame: 12 Month post-procedure
measure: Device success
timeFrame: 0 day post-procedure
measure: Procedural Success
timeFrame: 0 day post-procedure
measure: Clinical success
timeFrame: 0 - 5 days post-procedure
Other outcomes:
Locations:
city: Beijing
country: China
facility: Emergency general hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Tongren hospital, Capital medical university
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Shanghai
country: China
facility: ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese
state: Shanghai
city: Shanghai
country: China
facility: Huashan hospital affiliated to FuDan university
state: Shanghai
city: Shanghai
country: China
facility: Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Taiyuan
country: China
facility: Taiyuan Central Hospital
state: Shanxi
city: Hangzhou
country: China
facility: Shaoyifu hospital, zhejiang medical universiyt
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: ShuGuang Hospital affiliated to Shanghai University of Traditional Chinese
name: YE CHAOYANG
role: STUDY_CHAIR
References: