A Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With APERTO

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Peripheral Arterial Disease Fistula

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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APERTO OTW group

in the APERTO OTW group the subject will be treated with APERTO OTW balloon (Paclitaxel Releasing Peripheral Balloon Dilatation Catheter)

Group Type EXPERIMENTAL

Paclitaxel Releasing Peripheral Balloon Dilatation Catheter

Intervention Type DEVICE

Treatment group

OHICHO II group

in the OHICHO II group the subject will be treated with OHICHO II balloon (Balloon Dilatation Catheter)

Group Type ACTIVE_COMPARATOR

Balloon Dilatation Catheter

Intervention Type DEVICE

Control group

Interventions

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Paclitaxel Releasing Peripheral Balloon Dilatation Catheter

Treatment group

Intervention Type DEVICE

Balloon Dilatation Catheter

Control group

Intervention Type DEVICE

Other Intervention Names

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APERTO OTW OHICHO II

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No