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A Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With APERTO

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ClinicalTrials.gov Identifier: NCT02962141
Recruitment Status : Completed
First Posted : November 11, 2016
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
ZhuHai Cardionovum Medical Device Co., Ltd.

Tracking Information
First Submitted Date  ICMJE November 8, 2016
First Posted Date  ICMJE November 11, 2016
Last Update Posted Date August 7, 2019
Study Start Date  ICMJE October 2016
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2016)
  • 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.
  • 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).
  • 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.
  • 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)
  • MAE rates (death or stroke) [ Time Frame: 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))
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2016)
  • 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.
  • 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).
  • 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). 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.
  • 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)
  • MAE rates (death or stroke) [ Time Frame: 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))
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With APERTO
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Peripheral Arterial Disease
  • Fistula
Intervention  ICMJE
  • Device: Paclitaxel Releasing Peripheral Balloon Dilatation Catheter
    Treatment group
    Other Name: APERTO OTW
  • Device: Balloon Dilatation Catheter
    Control group
    Other Name: OHICHO II
Study Arms  ICMJE
  • Experimental: APERTO OTW group
    in the APERTO OTW group the subject will be treated with APERTO OTW balloon (Paclitaxel Releasing Peripheral Balloon Dilatation Catheter)
    Intervention: Device: Paclitaxel Releasing Peripheral Balloon Dilatation Catheter
  • Active Comparator: OHICHO II group
    in the OHICHO II group the subject will be treated with OHICHO II balloon (Balloon Dilatation Catheter)
    Intervention: Device: Balloon Dilatation Catheter
Publications * Yin Y, Shi Y, Cui T, Li H, Chen J, Zhang L, Yu Z, Li H, Yan Y, Wu K, Jin Q. Efficacy and Safety of Paclitaxel-Coated Balloon Angioplasty for Dysfunctional Arteriovenous Fistulas: A Multicenter Randomized Controlled Trial. Am J Kidney Dis. 2021 Jul;78(1):19-27.e1. doi: 10.1053/j.ajkd.2020.11.022. Epub 2021 Jan 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2018)
161
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2016)
160
Actual Study Completion Date  ICMJE June 2019
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02962141
Other Study ID Numbers  ICMJE APERTO-2015-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party ZhuHai Cardionovum Medical Device Co., Ltd.
Study Sponsor  ICMJE ZhuHai Cardionovum Medical Device Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Qizhuang Jin, professor Peking University First Hospital
PRS Account ZhuHai Cardionovum Medical Device Co., Ltd.
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP