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

Vascular Diseases Clinical Trial

Official title:

Drug Eluting Balloon (DEB) vs Plain Old Balloon Angioplasty (POBA) for the Treatment of Failing Dialysis Access. A Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05173857
• Other study ID #: TF1
• Status: Completed
• Phase: N/A
• Start date: March 1, 2014
• Est. completion date: July 31, 2018

Study information

• Verified date: December 2021
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: July 31, 2018
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Thrombosed access

• In stent restenosis

• Pregnancy

• Age less than 18 years

Related Conditions & MeSH terms

• Kidney Diseases
• Vascular Diseases

Intervention

Device:
• Advance PTX
PTA in Dysfunctional Haemodialysis Access
• Advance LP (Low Profile)
Plain Old Balloon Angioplasty (POBA)

Drug:
• Paclitaxel (PTX)
Paclitaxel (PTX)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Skane University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from restenosis in treated vascular access	Freedom from Restenosis and Target Lesion Revascularization (TLR) during 12 months follow up	12 months
Primary	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
Primary	Number of Participants with a vascular access in full clinical use for haemodialysis at 12 months	Functional status of vascular access.	12 months