DEB-after-Cutting Balloon-PTA in Dialysis Fistula Stenosis (DEB-after-CB)

October 16, 2015 updated by: Claas Philip Nähle, Cantonal Hospital of St. Gallen

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Switzerland
      • St. Gallen, Switzerland, 9007
        • Recruiting
        • Department of Radiology and Nuclear Medicine
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Dimitrios Tsinalis, MD
        • Sub-Investigator:
          • Aurelia Schnyder, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • dialysis fistula dysfunction requiring cutting balloon angioplasty

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: POBA-after-Cutting Balloon
After cutting balloon angioplasty, subsequent angioplasty is performed using a standard, non-coated balloon (plain old balloon, POBA).
Device: Angioplasty with plain old balloon
Angioplasty with plain old balloon "Sterling" (BostonScientific, Switzerland)
Other Names:
  • balloon "Sterling"
Active Comparator: DCB-after-Cutting Balloon
After cutting balloon angioplasty, subsequent angioplasty is performed using a drug-coated balloon (DCB)
Device: Angioplasty with drug-coated balloon
Angioplasty with drug-coated balloon "Elutax" (Aachen Resonance, Germany)
Other Names:
  • drug-coated balloon "Elutax"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to worsening of dialysis fistula function [days]
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in lumen 12 months after PTA [mm]
Time Frame: one year
aka "late lumen loss"
one year
Change in dialysis flow [ml/min.]
Time Frame: one year
one year
Change in dialysis fistula flow [ml/min.]
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cantonal Hospital of St. Gallen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

October 13, 2015

First Submitted That Met QC Criteria

October 16, 2015

First Posted (Estimate)

October 19, 2015

Study Record Updates

Last Update Posted (Estimate)

October 19, 2015

Last Update Submitted That Met QC Criteria

October 16, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EKSG 15/086

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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