NCT02578784

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 19, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 19, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

October 13, 2015

Last Update Submit

October 16, 2015

Conditions

Renal Insufficiency

Keywords

Dialysis

Outcome Measures

Primary Outcomes (1)

  • Time to worsening of dialysis fistula function [days]

    one year

Secondary Outcomes (3)

  • Change in lumen 12 months after PTA [mm]

    one year

  • Change in dialysis flow [ml/min.]

    one year

  • Change in dialysis fistula flow [ml/min.]

    one year

Study Arms (2)

POBA-after-Cutting Balloon

PLACEBO COMPARATOR

After cutting balloon angioplasty, subsequent angioplasty is performed using a standard, non-coated balloon (plain old balloon, POBA).

Device: Angioplasty with plain old balloon

DCB-after-Cutting Balloon

ACTIVE COMPARATOR

After cutting balloon angioplasty, subsequent angioplasty is performed using a drug-coated balloon (DCB)

Device: Angioplasty with drug-coated balloon

Interventions

Angioplasty with drug-coated balloonDEVICE

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

Also known as: drug-coated balloon "Elutax"
DCB-after-Cutting Balloon
Angioplasty with plain old balloonDEVICE

Angioplasty with plain old balloon "Sterling" (BostonScientific, Switzerland)

Also known as: balloon "Sterling"
POBA-after-Cutting Balloon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • dialysis fistula dysfunction requiring cutting balloon angioplasty

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiology and Nuclear Medicine

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndovascular ProceduresVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical ProceduresInvestigative Techniques

Central Study Contacts

Claas P Naehle, MD

CONTACT

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

Lukas Hechelhammer, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending, Department of Radiology and Nuclear Medicine

Study Record Dates

First Submitted

October 13, 2015

First Posted

October 19, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2018

Last Updated

October 19, 2015

Record last verified: 2015-10

Locations

CH(1)