A Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With APERTO

Not Applicable

Completed

• Conditions: Peripheral Arterial Disease; Fistula
• Interventions: Device: Paclitaxel Releasing Peripheral Balloon Dilatation Catheter; Device: Balloon Dilatation Catheter

• Registration Number: NCT02962141
• Lead Sponsor: ZhuHai Cardionovum Medical Device Co., Ltd.

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.

Study Timeline

• Study Start: 2016-10
• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-09
• Study First Posted: 2016-11-11
• Primary Completion: 2018-01
• Study Completion: 2019-06
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-06
• Last Update Posted: 2019-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
APERTO OTW group	Paclitaxel Releasing Peripheral Balloon Dilatation Catheter	in the APERTO OTW group the subject will be treated with APERTO OTW balloon (Paclitaxel Releasing Peripheral Balloon Dilatation Catheter)
OHICHO II group	Balloon Dilatation Catheter	in the OHICHO II group the subject will be treated with OHICHO II balloon (Balloon Dilatation Catheter)

Primary Outcome Measures

Name	Time	Method
Primary patency rate of the target lesion	at 6 month post procedure	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.

Secondary Outcome Measures

Name	Time	Method
MAE rates (death or stroke)	at 1 month, 3 months, 6 months, and 12 months post procedure.
The diameter stenosis rate in target lesion	at 6 months post procedure	The diameter stenosis (%)=100% × (1-(MLD/RVD))
Clinical-driven Target Lesion Revascularization (CD-TLR)	in1st, 3rd, 6th, 12th month post operation	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.
Clinical Success	at 1 month	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.
Clinical-driven Target Shunt Revascularization (CD-TSR)	in 1st, 3rd, 6th, 12th month post operation	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.
Device Success	intraoperative	Device Success is defined as ability of the Device to be delivered, inflated at pressure ≤ RBP, and retrieved from the Target Lesion without burst.
Technical Success	intraoperative	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).
Procedural Success	at 1 month	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)

Trial Locations

Locations (9)

Hainan General Hospital; 🇨🇳 Haikou, Hainan, China

The First Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China

The First Hospital of Zhejiang Province; 🇨🇳 Hangzhou, Zhejiang, China

Beijing Tongren Hospital, Capital Medical University; 🇨🇳 Beijing, China

Sir Run Run Shaw Hospital School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

Longhua Hospital Shanghai University of Tranditional Chinese Medicine; 🇨🇳 Shanghai, China