DCB for Dialysis Access Stent Graft Restenosis

A Randomized Trial Comparing Drug-coated Balloon and Regular Balloon for Dialysis Access Stent Graft Restenosis

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.

Study Overview

• Status: Unknown
• Conditions: Hemodialysis Access Failure (Disorder); Stent-Graft Restenosis; Arteriovenous Graft; Drug-coated Balloon
• Intervention / Treatment: Device: Regular balloon; Device: DCB (paclitaxel-coated balloon)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Hsinchu City
    • Hsinchu, Hsinchu City, Taiwan, 300
      • Recruiting
      • National Taiwan University Hospital Hsinchu Branch
      • Contact: Chiu-Kuei Nien, RN; Phone Number: 8853 886-35326151; Email: hch01215@hch.gov.tw
      • Contact: Jen-Jin Chen, RN; Phone Number: 8665 886-35326151; Email: cychen1@hch.gov.tw
      • Sub-Investigator: Min-Tsun Liao, MD
      • Sub-Investigator: Mu-Yang Hsieh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Regular balloon; Use the regular balloon to perform standard balloon angioplasty.	Device: Regular balloon; Randomization: to use regular balloon to treat stent graft restenosis
Active Comparator: DCB (paclitaxel-coated balloon); Use DCB (paclitaxel-coated balloon) to perform additional balloon angioplasty.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late luminal loss	The late luminal loss found by IVUS on follow-up in comparison to index procedure.	0, 1, and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
minimal luminal area and diameter	Done by IVUS on follow-up in comparison to index procedure.	0, 1, and 3 months
restenosis rate	Compare with follow-up angiography.	0, 1, and 3 months
repeated intervention	defined by repeated endovascular balloon angioplasty or endovascular thrombectomy or surgical open thrombectomy.	0, 1, and 3 months
abandon of AV graft, death	stopped to use the target AVG or mortality	0, 1, and 3 months

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital Hsin-Chu Branch
• Investigators: Principal Investigator: Mu-Yang Hsieh, MD, National Taiwan University Hospital Hsin-Chu Branch

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: November 12, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Actual): December 4, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: 105-015-F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No