Clinical trial NCT02962141: A Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With APERTO
Official title: Evaluation of the Safety and Efficacy of the Paclitaxel Eluting Hemodialysis Shunt Balloon Dilatation Catheter (APERTO) in Treatment of Hemodialysis Arteriovenous Fistulae Stenosis: A Prospective, Multicenter, Randomized, Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Fistula
Keywords: drug eluting balloon, Arteriovenous Fistulae
Lead sponsor: ZhuHai Cardionovum Medical Device Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-11-11
Enrollment: 161
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: To evaluate the safety and efficacy of Paclitaxel Eluting Hemodialysis Shunt Balloon Dilatation Catheter (APERTO) compared with the Balloon Dilatation catheter (OHICHO II) for the treatment of Arteriovenous Fistulae Stenosis in patients undergoing hemodialysis.

Detailed description: To evaluate the safety and efficacy of the Paclitaxel Eluting Hemodialysis Shunt Balloon Dilatation Catheter (APERTO) compared with the Balloon Dilatation catheter (OHICHO II) for the treatment of Arteriovenous Fistulae Stenosis in patients undergoing hemodialysis.

This is a prospective, multi-center, randomized controlled, open-label, superiority study. A total of 160 subjects will be enrolled from 10 sites in China. All subjects enrolled will be randomly assigned to the test group (APERTO group, n=80) and the control group (OHICHO II group, n=80) with randomized allocation ratio of 1:1. Subjects in the test group and the control group will be treated with APERTO OTW or OHICHO II respectively.

Eligibility criteria: Inclusion criteria:

Patients must meet all of the following criteria:

* Age ≥ 18 years and ≤ 75 years, male or female.
* Patient or legally authorized representative can understand the purpose of this clinic trial. He or She volunteers to participate in this trial and can provide written informed consent, and is willing to accept the scheduled follow-up in specific time points.
* Angiography, ultrasound or clinical diagnosis shows that patients have hemodialysis access dysfunction due to stenosis lesions.
* Patients with indications of the percutaneous endovascular therapy, that is, the AVF stenosis is related to hemodynamics and ≥ 50%, and with any of the following clinical and physiological abnormalities (referred to NKF-K/DOQI guideline definitions):

  1. Thrombosis in the AVF;
  2. Elevated venous pressure during dialysis
  3. Obvious abnormality in recirculation measurements
  4. Abnormal physical examination findings
  5. Unexplained decreases in dialysis dose
  6. Decreased access flow
* Target lesion is a de novo or restenosis. The number of target lesions is 1.
* Target lesion consists of a single lesion or a multiple lesions with target lesion length ≤ 40 mm.
* Target lesion(s) is located in the reflux vein which is from the anastomosis of native arteriovenous fistula (AVF) to the distal end of subclavian vein, except the anastomosis of native AVF.
* If patient has non-target lesion, it must be successfully treated using PTA before treating target lesion.
* Reference vessel diameter of target lesion ≥ 4.0 mm and ≤ 7.0 mm by visual estimate (determined by angiography or DUS).
* Hemodialysis access previously used (mature AVF) can no longer be successfully used due to insufficient shunt flow volume caused by local lumen stenosis.

Exclusion criteria:

Patients will be excluded if any of the following conditions applies:

* Patients who have participated in another investigational drug or device trial.
* Patients who have been enrolled in this trial previously.
* Women of childbearing age with negative pregnancy test before procedure, and breastfeeding women.
* Any major surgical procedure (such as thoracotomy, craniotomy, etc.) within 30 days prior to the procedure.
* Any planned major surgical procedure (such as thoracotomy, craniotomy, etc.) within 30 days of entry into this study
* Immature AVF, which cannot be used for Dialysis or has not been used successfully due to insufficient lumen diameter to ensure successfully puncture and insufficient shunt flow volume.
* Patients with AVG.
* AVF has been previously implanted with stent.
* Lesion in AVF has been previously treated with DEB.
* Target lesion is located in the anastomosis of native AVF.
* Known allergies or intolerance to Paclitaxel or contrast medium.
* Life expectancy \< 1 year
* Patients with comitans systemic lupus erythematosus and ANCA associated vasculitis.

Primary outcomes:
measure: Primary patency rate of the target lesion
timeFrame: at 6 month post procedure
Secondary outcomes:
measure: Device Success
timeFrame: intraoperative
measure: Technical Success
timeFrame: intraoperative
measure: Clinical Success
timeFrame: at 1 month
measure: Procedural Success
timeFrame: at 1 month
measure: MAE rates (death or stroke)
timeFrame: at 1 month, 3 months, 6 months, and 12 months post procedure.
measure: The diameter stenosis rate in target lesion
timeFrame: at 6 months post procedure
measure: Clinical-driven Target Lesion Revascularization (CD-TLR)
timeFrame: in1st, 3rd, 6th, 12th month post operation
measure: Clinical-driven Target Shunt Revascularization (CD-TSR)
timeFrame: in 1st, 3rd, 6th, 12th month post operation
Other outcomes:
Locations:
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
state: Hebei
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University
state: Hunan
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital School of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The First Hospital of Zhejiang Province
state: Zhejiang
city: Beijing
country: China
facility: Beijing Tongren Hospital, Capital Medical University
city: Shanghai
country: China
facility: Longhua Hospital Shanghai University of Tranditional Chinese Medicine
Study officials:
affiliation: Peking University First Hospital
name: Qizhuang Jin, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yin Y, Shi Y, Cui T, Li H, Chen J, Zhang L, Yu Z, Li H, Yan Y, Wu K, Jin Q. Efficacy and Safety of Paclitaxel-Coated Balloon Angioplasty for Dysfunctional Arteriovenous Fistulas: A Multicenter Randomized Controlled Trial. Am J Kidney Dis. 2021 Jul;78(1):19-27.e1. doi: 10.1053/j.ajkd.2020.11.022. Epub 2021 Jan 5.