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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
161
Treatment group
Control group
Hainan General Hospital
Haikou, Hainan, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Primary patency rate of the target lesion
Primary patency is defined as freedom from restenosis as determined by DUS Peak Systolic Velocity Ratio (PSVR) ≤ 2.0 and freedom from clinically-driven target lesion revascularization (CD-TLR). Restenosis is defined as PSVR\> 2.0 determined by independent DUS laboratory. Clinically-driven target lesion revascularization (CD-TLR) is defined as any re-intervention in target lesion (+/-5mm proximal or distal of the target lesion) determined by DUS due to clinical symptoms or dialysis indicators showing that it is unable to perform dialysis.
Time frame: at 6 month post procedure
Device Success
Device Success is defined as ability of the Device to be delivered, inflated at pressure ≤ RBP, and retrieved from the Target Lesion without burst.
Time frame: intraoperative
Technical Success
Technical Success is defined as the residual stenosis of the lumen diameter ≤ 30% after treatment with either APERTO OTW or OHICHO II (compared with the referred vessel diameter of the nearest veins with no aneurysm).
Time frame: intraoperative
Clinical Success
Clinical Success is defined as improvement in hemodialysis access function and resumption of normal dialysis for at least one dialysis session after the index procedure.
Time frame: at 1 month
Procedural Success
Procedural Success is defined as technical success without the occurrence of MAE during the hospitalization or day of treatment (MAE defined here as: death, stroke, thrombotic occlusion, allergic reaction, pulmonary events (including pulmonary edema)
Time frame: at 1 month
MAE rates (death or stroke)
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The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Sir Run Run Shaw Hospital School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
The First Hospital of Zhejiang Province
Hangzhou, Zhejiang, China
Beijing Tongren Hospital, Capital Medical University
Beijing, China
Longhua Hospital Shanghai University of Tranditional Chinese Medicine
Shanghai, China
Time frame: at 1 month, 3 months, 6 months, and 12 months post procedure.
The diameter stenosis rate in target lesion
The diameter stenosis (%)=100% × (1-(MLD/RVD))
Time frame: at 6 months post procedure
Clinical-driven Target Lesion Revascularization (CD-TLR)
CD-TLR is defined as any re-intervention in target lesion (+/-5mm proximal or distal of the target lesion) determined by DUS due to clinical symptoms or dialysis indicators showing that it is unable to perform dialysis.
Time frame: in1st, 3rd, 6th, 12th month post operation
Clinical-driven Target Shunt Revascularization (CD-TSR)
Target Shunt is defined as the reflux vein, which is from the anastomotic stoma of native arteriovenous fistula (AVF) to the distal end of the subclavian vein. CD-TSR is defined as any re-intervention in target lesion due to clinical symptoms or inability to perform dialysis.
Time frame: in 1st, 3rd, 6th, 12th month post operation