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DCB for Dialysis Access Stent Graft Restenosis

NCT ID: NCT03360279

Last Updated: 2017-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-05

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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Prosthetic arteriovenous hemodialysis access graft (AVG) has high incidences of venous anastomotic stenosis and access failure. A stent graft can be used in AVG with recurrent venous anastomotic stenosis to improve long-term patency rate. However, after stent graft implementation, the effective treatment for restenosis in a stent graft is still unknown. This randomized trial is designed to evaluate the efficacy and safety of drug-coated balloon versus regular balloon for in-stent restenosis in stent graft. The investigators plan to enroll 40 patients who presented with prosthetic AVG in-stent restenosis, and then to evaluate the restenosis lesions by intravascular ultrasound. Patients will be randomized into two groups of treatment: drug-coated balloon angioplasty or regular balloon angioplasty.

Conditions

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Hemodialysis Access Failure (Disorder) Stent-Graft Restenosis Arteriovenous Graft Drug-coated Balloon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The IVUS interpreter and follow-up evaluators are masked.

Study Groups

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Regular balloon

Use the regular balloon to perform standard balloon angioplasty.

Group Type ACTIVE_COMPARATOR

Regular balloon

Intervention Type DEVICE

Randomization: to use regular balloon to treat stent graft restenosis

DCB (paclitaxel-coated balloon)

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

Group Type ACTIVE_COMPARATOR

DCB (paclitaxel-coated balloon)

Intervention Type 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.

Interventions

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Regular balloon

Randomization: to use regular balloon to treat stent graft restenosis

Intervention Type DEVICE

DCB (paclitaxel-coated balloon)

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital Hsin-Chu Branch

OTHER

Sponsor Role lead

Responsible Party

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IRB of NTUH Hsin-Chu Branch

Mu-Yang Hsieh MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mu-Yang Hsieh, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital Hsin-Chu Branch

Locations

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National Taiwan University Hospital Hsinchu Branch

Hsinchu, Hsinchu City, Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Mu-Yang Hsieh, MD

Role: CONTACT

Phone: 886-35326151

Email: [email protected]

Chih-Cheng Wu, MD

Role: CONTACT

Phone: 886-35326151

Email: [email protected]

Facility Contacts

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Chiu-Kuei Nien, RN

Role: primary

Jen-Jin Chen, RN

Role: backup

References

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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.

Reference Type DERIVED
PMID: 37209996 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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105-015-F

Identifier Type: -

Identifier Source: org_study_id