RCT of Paclitaxel DEB Compared to Standard PTA in Dialysis Fistula

NCT02558153 | Completed

• 1 other identifier: NL44059.058.13
• Study Type: interventional
• Target: 105
• Locations: 2 countries
• Sites: 10

Brief Summary

A multicenter randomized clinical trial of paclitaxel drug-eluting balloon (DEB) versus standard percutaneous transluminal angioplasty (PTA) to reduce restenosis in 150 patients with haemodialysis access stenoses.

Conditions

Complication of Hemodialysis; Vascular Access Complication

Keywords

drug eluting balloon; percutaneous balloon angioplasty

Outcome Measures

Primary Outcomes (1)

• Adequate functioning of the hemodialysis access

  Period of adequate functioning of the hemodialysis access after treatment, defined according to the NKF-DOQI protocol criteria

  12 months

Secondary Outcomes (9)

• device success

  index procedure (day 0)

• Technical Success

  index procedure (day 0)

• Clinical Success

  12 months

• Procedural Success

  Index procedure (day 0)

• MAE - major adverse events

  12 months

Study Arms (2)

DEB - drug eluting balloon (APERTO)

EXPERIMENTAL

Percutaneous balloon angioplasty performed with the investigational device, the paclitaxel eluting APERTO balloon

Device: DEB, drug eluting balloon

standard PTA

ACTIVE COMPARATOR

Percutaneous balloon angioplasty performed with the clinical standard, that is, a non-drug-eluting balloon (POBA, plain old balloon angioplasty).

Device: standard PTA

Interventions

DEB, drug eluting balloon DEVICE

Percutaneous angioplasty performed with a DEB - drug eluting balloon

Also known as: Paclitaxel eluting balloon

DEB - drug eluting balloon (APERTO)

standard PTA DEVICE

Percutaneous angioplasty performed with a standard balloon

Also known as: POBA

standard PTA

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years and \< 90 years
• Patient or legally authorized representative providing written informed consent
• Patient willing and likely to comply with the follow up schedule
• Patients with previously well functioning hemodialysis access on the arm presenting with any of the following clinical abnormalities as defined in the NKF-DOQI-protocol criteria (National Kidney Foundation 2000):
• Abnormal physical examination findings (change in bruits, thrill, pulse, etc
• Abnormal urea recirculation measurements
• Elevated venous pressure during dialysis
• Decreased access flow
• Previous thrombosis in the access line
• Development of collateral veins
• Limb swelling
• Low arterial pressure during dialysis
• Unexplained decreases in dialysis dose
• Target Lesion is hemodynamically relevant and consists of MLD ≤ 3 mm. For enrolment this criterium is judged by the local investigator. For final analysis this criterium is based on the result of central reading of the angiogram.
• Target Lesion(s) is a de-novo or (non-stent) restenosis

You may not qualify if:

• Patients unable to give informed consent
• Patients enrolled in another study with any investigational drug or device
• Patients previously enrolled in the APERTO trial.
• Female patients of child bearing potential without a negative pregnancy test at the time of intervention
• Major surgical procedures within 30 days prior to this study or planned within 30 days of entry into this study
• Patients previously treated with a DEB in the hemodialysis access.
• Patients with a trombosed hemodialysis access.
• Immature hemodialysis access (unusable due to insufficient shunt flow volume)
• Lesion treated within 30 days prior to screening
• Failure to successfully treat non-target lesions prior the Target Lesion
• In stent restenosis
• Patients with any known allergy, hypersensitivity or intolerance to ASA, clopidogrel or ticlopidine, paclitaxel, or contrast medium.
• Graft infection
• Life expectancy \< 1 years

Sponsors & Collaborators

• Groene Hart Ziekenhuis: lead
• Archer Research: collaborator

Study Sites (10)

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

Location

ZNA Stuivenberg

Antwerp, 2060, Belgium

Location

Atrium Medisch Centrum. Department of radiology

Heerlen, Limburg, 6419 PC, Netherlands

Location

Catharina ziekenhuis

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

St Lucas Andreas Hospital

Amsterdam, North Holland, 1061 AE, Netherlands

Location

MC Leeuwarden

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

Location

Groene Hart Ziekenhuis

Gouda, South Holland, 2803 HH, Netherlands

Location

Erasmus MC

Rotterdam, South Holland, 3015CE, Netherlands

Location

MC Haaglanden

The Hague, South Holland, 2512 VA, Netherlands

Location

UMC Groningen

Groningen, 9700 RB, Netherlands

Location

Study Officials

• Peter MT Pattynama, MD, PhD

  Groene Hart Ziekenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD. Interventional radiologist

Study Record Dates

• First Submitted: June 7, 2015
• First Posted: September 23, 2015
• Study Start: June 1, 2015
• Primary Completion: July 3, 2019
• Study Completion: July 3, 2019
• Last Updated: May 5, 2020

Record last verified: 2020-05

Locations

BE (2); NL (8)