NCT03360279

Brief Summary

Recurrent stenosis in hemodialysis access graft (AVG) is difficult to treat. For recurrent stenosis in the anastomotic junction can be treated by stent graft to improve long-term patency. However, there is no data regarding treatment of stent graft restenosis in AVG. This randomized trial is designed to compare the efficacy and safety of drug-coated balloon (DCB) versus regular balloon in AVG stent graft restenosis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 5, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 4, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

December 4, 2017

Status Verified

November 1, 2017

Enrollment Period

2.8 years

First QC Date

November 12, 2017

Last Update Submit

November 27, 2017

Conditions

Hemodialysis Access Failure (Disorder)Stent-Graft RestenosisArteriovenous GraftDrug-coated Balloon

Outcome Measures

Primary Outcomes (1)

  • Late luminal loss

    The late luminal loss found by IVUS on follow-up in comparison to index procedure.

    0, 1, and 3 months

Secondary Outcomes (4)

  • minimal luminal area and diameter

    0, 1, and 3 months

  • restenosis rate

    0, 1, and 3 months

  • repeated intervention

    0, 1, and 3 months

  • abandon of AV graft, death

    0, 1, and 3 months

Study Arms (2)

Regular balloon

ACTIVE COMPARATOR

Use the regular balloon to perform standard balloon angioplasty.

Device: Regular balloon

DCB (paclitaxel-coated balloon)

ACTIVE COMPARATOR

Use DCB (paclitaxel-coated balloon) to perform additional balloon angioplasty.

Device: DCB (paclitaxel-coated balloon)

Interventions

Regular balloonDEVICE

Randomization: to use regular balloon to treat stent graft restenosis

Regular balloon
DCB (paclitaxel-coated balloon)DEVICE

Randomization: to use DCB (paclitaxel-coated balloon, Ranger, Boston-Scientific) to treat stent graft restenosis. The paclitaxel dose is 2 ug/mm2 delivered with the Ranger drug-coated balloon.

DCB (paclitaxel-coated balloon)

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 20 to 90 years on regular hemodialysis at least 3 months
  • Had stent graft implemented at dialysis vascular access
  • Angiographic evidence of stenosis within the stent graft or less than 2 cm from the stent graft edge
  • Clinical evidence of a hemodynamically significant stenosis or thrombosis
  • Patient is able to provide written informed consent

You may not qualify if:

  • Elbow fracture or any disease involve the elbow joint that prohibits the flexion maneuver.
  • Target lesion cannot be crossed by the guide wire.
  • Known hypersensitivity to heparin or contrast medium.
  • Bleeding diathesis.
  • Patients participating in another clinical trial with interfering with this trial in the past three months.
  • Untreatable bleeding diathesis.
  • Other diseases, such as cancer, liver disease, or cardiac insufficiency, which may lead to protocol violations or markedly shorten a patient's life expectancy (less than 3 months).
  • Patients unable or unwilling to participate this trial.
  • Pregnancy, lactating woman, non-adult, criminals in sentence, psychiatric patients, research staffs or colleagues are prohibited.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital Hsinchu Branch

Hsinchu, Hsinchu City, 300, Taiwan

RECRUITING

Related Publications (1)

  • Hsieh MY, Lin PS, Liao MT, Lin L, Chen TY, Boon JC, Yang TF, Wu CC. A Randomised Trial Comparing Drug Coated Balloons and Conventional Balloons for the Treatment of Stent Graft Stenosis in Dialysis Vascular Access. Eur J Vasc Endovasc Surg. 2023 Aug;66(2):253-260. doi: 10.1016/j.ejvs.2023.05.028. Epub 2023 May 18.

    PMID: 37209996DERIVED

Study Officials

  • Mu-Yang Hsieh, MD

    National Taiwan University Hospital Hsin-Chu Branch

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mu-Yang Hsieh, MD

CONTACT

886-35326151h11135@hch.gov.tw

Chih-Cheng Wu, MD

CONTACT

886-35326151chihchengwumd@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The IVUS interpreter and follow-up evaluators are masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mu-Yang Hsieh MD

Study Record Dates

First Submitted

November 12, 2017

First Posted

December 4, 2017

Study Start

March 5, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

December 4, 2017

Record last verified: 2017-11

Locations

TW(1)