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

Prospective, Randomized Trial on the Clinical Utility of Drug-coated Balloons After Angioplasty of Plain Old Balloon-resistent Dialysis Fistula Stenosis Using Cutting Ballons

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02578784

Acronym

DEB-after-CB

Enrollment

Registered

2015-10-19

Start date

2015-10-31

Completion date

2018-10-31

Last updated

2015-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Insufficiency

Keywords

Dialysis

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.

Interventions

DEVICEAngioplasty with drug-coated balloon

Angioplasty with drug-coated balloon Elutax (Aachen Resonance, Germany)

DEVICEAngioplasty with plain old balloon

Angioplasty with plain old balloon Sterling (BostonScientific, Switzerland)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* dialysis fistula dysfunction requiring cutting balloon angioplasty

Exclusion criteria

* missing informed consent or unable to consent * age \< 18 years * pregnancy

Design outcomes

Primary

Measure	Time frame
Time to worsening of dialysis fistula function [days]	one year

Secondary

Measure	Time frame	Description
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	—

Countries

Switzerland

Contacts

Primary ContactClaas P Naehle, MD

claasphilip.naehle@kssg.ch+41-71-494

Backup ContactLukas Hechelhammer, MD

lukas.hechelhammer@kssg.ch+41-71-494

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026