Drug Eluting Balloon (DEB) vs Plain Old Balloon Angioplasty (POBA) in the Treatment of Failing Dialysis Access

NCT05173857 | Completed

• 1 other identifier: TF1
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background Conventional percutaneous transluminal angioplasty is still considered standard treatment for treatment of dysfunctional haemodialysis fistulas and grafts. The most important drawback with this treatment is frequent restenosis leading to a high number of secondary procedures. There is conflicting evidence in the literature regarding primary or secondary treatment with drug eluting balloons (DEB). These balloons deliver Paclitaxel locally, which acts as an antiproliferative drug and may improve treatment outcomes. Methods This study was conducted as a prospective 1:1 randomized single centre clinical trial. Participants had primary or re-stenotic lesions in native upper extremity arteriovenous fistulas or at the graft-venous anastomosis. Patients were randomized to direct primary dilatation, with either a standard balloon or a DEB. The primary effectiveness endpoints were freedom from target lesion revascularization (TLR), access circuit revascularization or thrombosis, functional status of access circuit at 12 months. Secondary endpoints were procedural complications, procedural success, follow up survival and time to target lesion revascularization.

Conditions

Vascular Diseases; Kidney Diseases

Keywords

Haemodialysis; Fistula; Stenosis; Paclitaxel; Drug-eluting balloon; Angioplasty

Outcome Measures

Primary Outcomes (3)

• Freedom from restenosis in treated vascular access

  Freedom from Restenosis and Target Lesion Revascularization (TLR) during 12 months follow up

  12 months

• Stenosis or occlusion in treated vascular access

  Treated Denovo Stenosis or Occlusion during 12 months follow up, i.e a new stenosis \>50%, not treated before in the study, and at another location in the vascular access circuit (upper arm haemodialysis access)

  12 months

• Number of Participants with a vascular access in full clinical use for haemodialysis at 12 months

  Functional status of vascular access.

  12 months

Study Arms (2)

Drug Eluting Balloon (DEB)

ACTIVE COMPARATOR

Percutaneous Angioplasty in dysfunctional arteriovenous access, using Drug Eluting Balloon Technology. Drug: Paclitaxel (PTX). Name of Device: Advance PTX

Device: Advance PTX; Drug: Paclitaxel (PTX)

Plain Old Balloon Angioplasty (POBA)

PLACEBO COMPARATOR

Percutaneous Angioplasty in dysfunctional arteriovenous access, using Plain Old Balloon Angioplasty. Drug: None. Name of Device: Advance LP (Low Profile)

Device: Advance LP (Low Profile)

Interventions

Advance PTX DEVICE

PTA in Dysfunctional Haemodialysis Access

Drug Eluting Balloon (DEB)

Advance LP (Low Profile) DEVICE

Plain Old Balloon Angioplasty (POBA)

Plain Old Balloon Angioplasty (POBA)

Paclitaxel (PTX) DRUG

Paclitaxel (PTX)

Drug Eluting Balloon (DEB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active dialysis with a mature upper extremity dysfunctional haemodialysis access
• Primary stenosis or nonstented restenosis in a native AV fistula or at graft-venous location
• Adult (\>18 years)
• Target vessel diameter 3-8mm

You may not qualify if:

• Thrombosed access
• In stent restenosis
• Pregnancy
• Age less than 18 years

Sponsors & Collaborators

• Skane University Hospital: lead

MeSH Terms

Conditions

Vascular Diseases; Kidney Diseases; Fistula; Constriction, Pathologic

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Vascular Surgeon

Study Record Dates

• First Submitted: November 10, 2021
• First Posted: December 30, 2021
• Study Start: March 1, 2014
• Primary Completion: July 31, 2017
• Study Completion: July 31, 2018
• Last Updated: January 14, 2022

Record last verified: 2021-12