NCT02962141

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

1.3 years

First QC Date

November 8, 2016

Last Update Submit

August 6, 2019

Conditions

Peripheral Arterial DiseaseFistula

Keywords

drug eluting balloon, Arteriovenous Fistulae

Outcome Measures

Primary Outcomes (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.

    at 6 month post procedure

Secondary Outcomes (8)

  • Device Success

    intraoperative

  • Technical Success

    intraoperative

  • Clinical Success

    at 1 month

  • Procedural Success

    at 1 month

  • MAE rates (death or stroke)

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

  • +3 more secondary outcomes

Study Arms (2)

APERTO OTW group

EXPERIMENTAL

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

OHICHO II group

ACTIVE COMPARATOR

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

Device: Balloon Dilatation Catheter

Interventions

Paclitaxel Releasing Peripheral Balloon Dilatation CatheterDEVICE

Treatment group

Also known as: APERTO OTW
APERTO OTW group
Balloon Dilatation CatheterDEVICE

Control group

Also known as: OHICHO II
OHICHO II group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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.
  • +2 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Hainan General Hospital

Haikou, Hainan, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Location

Sir Run Run Shaw Hospital School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Location

The First Hospital of Zhejiang Province

Hangzhou, Zhejiang, China

Location

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Location

Longhua Hospital Shanghai University of Tranditional Chinese Medicine

Shanghai, China

Location

Related Publications (1)

  • 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.

    PMID: 33418016DERIVED

MeSH Terms

Conditions

Peripheral Arterial DiseaseFistula

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Qizhuang Jin, professor

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2016

First Posted

November 11, 2016

Study Start

October 1, 2016

Primary Completion

January 1, 2018

Study Completion

June 1, 2019

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

CN(9)