A Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With APERTO

August 6, 2019 updated by: ZhuHai Cardionovum Medical Device Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

161

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Beijing Tongren Hospital, Capital Medical University
      • Shanghai, China
        • Longhua Hospital Shanghai University of Tranditional Chinese Medicine
    • Hainan
      • Haikou, Hainan, China
        • Hainan General Hospital
    • Hebei
      • Shijiazhuang, Hebei, China
        • The First Hospital of Hebei Medical University
    • Hunan
      • Changsha, Hunan, China
        • The Third Xiangya Hospital of Central South University
    • Jiangxi
      • Nanchang, Jiangxi, China
        • The First Affiliated Hospital Of Nanchang University
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital, Sichuan University
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Sir Run Run Shaw Hospital School of Medicine, Zhejiang University
      • Hangzhou, Zhejiang, China
        • The First Hospital of Zhejiang Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: APERTO OTW group
in the APERTO OTW group the subject will be treated with APERTO OTW balloon (Paclitaxel Releasing Peripheral Balloon Dilatation Catheter)
Device: Paclitaxel Releasing Peripheral Balloon Dilatation Catheter
Treatment group
Other Names:
  • APERTO OTW
Active Comparator: OHICHO II group
in the OHICHO II group the subject will be treated with OHICHO II balloon (Balloon Dilatation Catheter)
Device: Balloon Dilatation Catheter
Control group
Other Names:
  • OHICHO II

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary patency rate of the target lesion
Time Frame: 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.
at 6 month post procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Success
Time Frame: 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.
intraoperative
Technical Success
Time Frame: 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).
intraoperative
Clinical Success
Time Frame: 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.
at 1 month
Procedural Success
Time Frame: 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)
at 1 month
MAE rates (death or stroke)
Time Frame: at 1 month, 3 months, 6 months, and 12 months post procedure.
at 1 month, 3 months, 6 months, and 12 months post procedure.
The diameter stenosis rate in target lesion
Time Frame: at 6 months post procedure
The diameter stenosis (%)=100% × (1-(MLD/RVD))
at 6 months post procedure
Clinical-driven Target Lesion Revascularization (CD-TLR)
Time Frame: 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.
in1st, 3rd, 6th, 12th month post operation
Clinical-driven Target Shunt Revascularization (CD-TSR)
Time Frame: 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.
in 1st, 3rd, 6th, 12th month post operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZhuHai Cardionovum Medical Device Co., Ltd.

Investigators

  • Principal Investigator: Qizhuang Jin, professor, Peking University first hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

November 8, 2016

First Submitted That Met QC Criteria

November 9, 2016

First Posted (Estimate)

November 11, 2016

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APERTO-2015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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