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

Renal Insufficiency Clinical Trial

— DEB-after-CB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02578784
• Other study ID #: EKSG 15/086
• Status: Recruiting
• Phase: N/A
• First received: October 13, 2015
• Last updated: October 16, 2015
• Start date: October 2015
• Est. completion date: October 2018

Study information

• Verified date: October 2015
• Source: Cantonal Hospital of St. Gallen
• Contact: Claas P Naehle, MD
• Phone: +41-71-494
• Email: claasphilip.naehle[@]kssg.ch
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• dialysis fistula dysfunction requiring cutting balloon angioplasty

Exclusion Criteria:

• missing informed consent or unable to consent

• age < 18 years

• pregnancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Device:
• Angioplasty with drug-coated balloon
Angioplasty with drug-coated balloon "Elutax" (Aachen Resonance, Germany)
• Angioplasty with plain old balloon
Angioplasty with plain old balloon "Sterling" (BostonScientific, Switzerland)

Locations

Country	Name	City	State
Switzerland	Department of Radiology and Nuclear Medicine	St. Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hospital of St. Gallen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to worsening of dialysis fistula function [days]		one year	No
Secondary	Change in lumen 12 months after PTA [mm]	aka "late lumen loss"	one year	No
Secondary	Change in dialysis flow [ml/min.]		one year	No
Secondary	Change in dialysis fistula flow [ml/min.]		one year	No