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Peripheral Arterial DiseaseNCT02962141

A Study of Hemodialysis Arteriovenous Fistulae Stenosis Treated With APERTO

A study testing Paclitaxel Releasing Peripheral Balloon Dilatation Catheter and Balloon Dilatation Catheter in people with Peripheral Arterial Disease and Fistula, run by ZhuHai Cardionovum Medical Device Co., Ltd. at 9 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Peripheral Arterial Disease, Fistula
What is being tested?
Paclitaxel Releasing Peripheral Balloon Dilatation Catheter and Balloon Dilatation Catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
161 participants
Where
9 sitesChina
Study dates
Oct 2016to Jun 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
  • Thrombosis in the AVF;
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  • Elevated venous pressure during dialysis
  • Obvious abnormality in recirculation measurements
  • Abnormal physical examination findings
  • Unexplained decreases in dialysis dose
  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

China9 sites

  • Beijing Tongren Hospital, Capital Medical University

    Beijing

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan

  • West China Hospital, Sichuan University

    Chengdu, Sichuan

  • Hainan General Hospital

    Haikou, Hainan

  • Sir Run Run Shaw Hospital School of Medicine, Zhejiang University

    Hangzhou, Zhejiang

  • The First Hospital of Zhejiang Province

    Hangzhou, Zhejiang

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • Longhua Hospital Shanghai University of Tranditional Chinese Medicine

    Shanghai

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
Paclitaxel Releasing Peripheral Balloon Dilatation Catheter, Balloon Dilatation Catheter
Keywords
drug eluting balloon, Arteriovenous Fistulae
Medical subject headings
Peripheral Arterial Disease, Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paclitaxel Releasing Peripheral Balloon Dilatation CatheterDevice

    Also called APERTO OTW

    Treatment group

  • Balloon Dilatation CatheterDevice

    Also called OHICHO II

    Control group

Study groups in NCT02962141
Study groupRoleWhat they receive
APERTO OTW groupExperimentalin the APERTO OTW group the subject will be treated with APERTO OTW balloon (Paclitaxel Releasing Peripheral Balloon Dilatation Catheter)
Receives: Device: Paclitaxel Releasing Peripheral Balloon Dilatation Catheter
OHICHO II groupActive comparatorin the OHICHO II group the subject will be treated with OHICHO II balloon (Balloon Dilatation Catheter)
Receives: Device: Balloon Dilatation Catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: at 6 month post procedure

Secondary outcomes (8)

  1. 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.

    Measured: intraoperative

  2. 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).

    Measured: intraoperative

  3. 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.

    Measured: at 1 month

  4. 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)

    Measured: at 1 month

  5. MAE rates (death or stroke)

    Measured: at 1 month, 3 months, 6 months, and 12 months post procedure.

  6. The diameter stenosis rate in target lesion

    The diameter stenosis (%)=100% × (1-(MLD/RVD))

    Measured: at 6 months post procedure

  7. 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.

    Measured: in1st, 3rd, 6th, 12th month post operation

  8. 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.

    Measured: in 1st, 3rd, 6th, 12th month post operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionJan 2018
  4. Study completionJun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02962141
Sponsor's protocol ID
APERTO-2015-01
Status last verified
Aug 2019
First submitted
8 Nov 2016
Last updated
7 Aug 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

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.

    PubMed 33418016

Questions about this trial

What is this clinical trial studying?

A study testing Paclitaxel Releasing Peripheral Balloon Dilatation Catheter and Balloon Dilatation Catheter in people with Peripheral Arterial Disease and Fistula, run by ZhuHai Cardionovum Medical Device Co., Ltd. at 9 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary patency rate of the target lesion (time frame: at 6 month post procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02962141, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.

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