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

NCT ID: NCT02578784

Last Updated: 2015-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2018-10-31

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.

Conditions

Renal Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

POBA-after-Cutting Balloon

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

Group Type: PLACEBO_COMPARATOR

Angioplasty with plain old balloon

Intervention Type: DEVICE

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

DCB-after-Cutting Balloon

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

Group Type: ACTIVE_COMPARATOR

Angioplasty with drug-coated balloon

Intervention Type: DEVICE

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

Interventions

Angioplasty with drug-coated balloon

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

Intervention Type: DEVICE

Angioplasty with plain old balloon

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

Intervention Type: DEVICE

Other Intervention Names

drug-coated balloon "Elutax"; balloon "Sterling"

Eligibility Criteria

Inclusion Criteria

• dialysis fistula dysfunction requiring cutting balloon angioplasty

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cantonal Hospital of St. Gallen

OTHER

Sponsor Role: lead

Responsible Party

Claas Philip Nähle

Attending, Department of Radiology and Nuclear Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Radiology and Nuclear Medicine

Sankt Gallen, Canton of St. Gallen, Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Claas P Naehle, MD

Role: CONTACT

claasphilip.naehle@kssg.ch

+41-71-494 ext. 6628

Lukas Hechelhammer, MD

Role: CONTACT

lukas.hechelhammer@kssg.ch

+41-71-494 ext. 6627

Facility Contacts

Claas P Naehle, MD

Role: primary

claasphilip.naehle@kssg.ch

+41-71-494 ext. 6628

Lukas Hechelhammer, MD

Role: backup

lukas.hechelhammer@kssg.ch

+41-79-494 ext. 6627

Other Identifiers

EKSG 15/086

Identifier Type: -

Identifier Source: org_study_id