A Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With APERTO
Peripheral Arterial Disease, Fistula
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring drug eluting balloon, Arteriovenous Fistulae
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):
- Thrombosis in the AVF;
- Elevated venous pressure during dialysis
- Obvious abnormality in recirculation measurements
- Abnormal physical examination findings
- Unexplained decreases in dialysis dose
- 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.
Sites / Locations
- Hainan General Hospital
- The First Hospital of Hebei Medical University
- The Third Xiangya Hospital of Central South University
- The First Affiliated Hospital of Nanchang University
- West China Hospital, Sichuan University
- Sir Run Run Shaw Hospital School of Medicine, Zhejiang University
- The First Hospital of Zhejiang Province
- Beijing Tongren Hospital, Capital Medical University
- Longhua Hospital Shanghai University of Tranditional Chinese Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
APERTO OTW group
OHICHO II group
in the APERTO OTW group the subject will be treated with APERTO OTW balloon (Paclitaxel Releasing Peripheral Balloon Dilatation Catheter)
in the OHICHO II group the subject will be treated with OHICHO II balloon (Balloon Dilatation Catheter)