DEB-after-Cutting Balloon-PTA in Dialysis Fistula Stenosis

Not Applicable

• Conditions: Renal Insufficiency
• Interventions: Device: Angioplasty with plain old balloon; Device: Angioplasty with drug-coated balloon

• Registration Number: NCT02578784
• Lead Sponsor: Cantonal Hospital of St. Gallen

Brief Summary

The incidence of hemodynamically relevant dialysis fistula stenoses/obstructions after 1 year is between 60-90% (from 62.5 to 91% radiocephalic, brachiocephalic 70-84%, PTFE shunts 62-87%), necessitating a therapeutic measure to preserve dialysis access during this period in 1/3 of the patients. This therapeutic measure is a dilatation of the stenosis using a standard PTA balloon (POBA, plain old balloon angioplasty with a primary technical success rate of 50-79% \[2-4\].In turn, in 21-50% of the cases an insufficient PTA result is obtained (so-called POBA-resistant stenosis). In these cases, predilatation with a so-called cutting balloon (carrying with small knives on its surface) is performed, leading to a success rate of 89%. However, a problem is the high incidence of restenosis, which is about 40% for recurrent stenosis and over 10% in de novo stenosis.

The use of drug-coated balloon (DCB) in non-POBA resistant stenoses lead to a reduction in the restenosis rate of 35% to 5%. However, the effect of DCB in POBA resistant stenoses is unknown.

Therefore, the aim of this study is to evaluate the clinical benefit of the combined use of a cutting balloon and a drug-coated balloon in POBA resistant dialysis fistula stenoses compared to the sole use of a cutting balloon.

Detailed Description

Not available

Study Timeline

• Status Verified: 2015-10
• Study Start: 2015-10
• Study First Submitted: 2015-10-13
• Study First Submitted QC: 2015-10-16
• Last Update Submitted: 2015-10-16
• Study First Posted: 2015-10-19
• Last Update Posted: 2015-10-19
• Primary Completion: 2017-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• dialysis fistula dysfunction requiring cutting balloon angioplasty

Exclusion Criteria

• missing informed consent or unable to consent
• age < 18 years
• pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
POBA-after-Cutting Balloon	Angioplasty with plain old balloon	After cutting balloon angioplasty, subsequent angioplasty is performed using a standard, non-coated balloon (plain old balloon, POBA).
DCB-after-Cutting Balloon	Angioplasty with drug-coated balloon	After cutting balloon angioplasty, subsequent angioplasty is performed using a drug-coated balloon (DCB)

Primary Outcome Measures

Name	Time	Method
Time to worsening of dialysis fistula function [days]	one year

Secondary Outcome Measures

Name	Time	Method
Change in lumen 12 months after PTA [mm]	one year	aka "late lumen loss"
Change in dialysis flow [ml/min.]	one year
Change in dialysis fistula flow [ml/min.]	one year

Trial Locations

Locations (1)

Department of Radiology and Nuclear Medicine; 🇨🇭 St. Gallen, Switzerland