DCB for Dialysis Access Stent Graft Restenosis

Arteriovenous Graft Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03360279
• Other study ID #: 105-015-F
• Status: Recruiting
• Phase: N/A
• First received: November 12, 2017
• Last updated: November 27, 2017
• Start date: March 5, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: November 2017
• Source: National Taiwan University Hospital Hsin-Chu Branch
• Contact: Mu-Yang Hsieh, MD
• Phone: 886-35326151
• Email: h11135[@]hch.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Regular balloon
Randomization: to use regular balloon to treat stent graft restenosis
• 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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital Hsinchu Branch	Hsinchu	Hsinchu City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital Hsin-Chu Branch

Country where clinical trial is conducted

Taiwan, 

Outcome

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