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Trial registered on ANZCTR


Registration number
ACTRN12616000789460
Ethics application status
Approved
Date submitted
27/05/2016
Date registered
16/06/2016
Date last updated
23/04/2019
Date data sharing statement initially provided
23/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomized controlled trial for endovascular intervention for dysfunctional dialysis access with drug-coated balloon versus plain balloon angioplasty
Scientific title
Paclitaxel-eluting balloon Versus plain angioplasty balloon for dysfunctional dialysis access: a prospective double-blinded randomized controlled trial
Secondary ID [1] 289318 0
Nil known
Universal Trial Number (UTN)
U1111-1183-3052
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dysfunctional haemodialysis access 298916 0
Renal failure on haemodialysis 299028 0
Condition category
Condition code
Surgery 298993 298993 0 0
Surgical techniques
Renal and Urogenital 299084 299084 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Randomised trial where participants with dysfunctional haemodialysis access are assessed by pre-treatment duplex ultrasound. Patients will assessed, counselled and consented by the same vascular team.
They will then be allocated to receiving percutaneous transluminal angioplasty with either paclitaxel coated balloon or plain ( control) balloon.
A single one-off intervention will be performed the same vascular surgeon in the vascular operating theatre in the same hospital. Surgical techniques will be standardised, performed under local anaesthetic, diagnostic angiogram performed and the appropriate sized balloon inflated to 1 minute to nominal pressure. For device failure, further angioplasty is performed with introduction of a high-pressure balloon of appropriate size and inflation to appropriate pressure for three minutes. In case of a flow-limiting dissection, a bare metal nitinol stent of appropriate size is introduced and placed; and in case of a rupture, a covered stent of appropriate size is introduced and placed. A post-procedure angiogram is performed.
Intervention code [1] 294870 0
Treatment: Devices
Comparator / control treatment
Percutaneous transluminal angioplasty with plain angioplasty balloon
Control group
Active

Outcomes
Primary outcome [1] 298461 0
Target lesion primary patency rate at 12 months (functional dialysis access with <50% angiographic re-stenosis and without any repeat interventional procedures)
Timepoint [1] 298461 0
12 months post intervention
Secondary outcome [1] 324210 0
Device Success: Post-procedure angiogram with residual stenosis <30% without high pressure post-dilation
Timepoint [1] 324210 0
Post procedure angiogram is performed intraoperatively, immediately after angioplasty intervention
Secondary outcome [2] 324211 0
Technical success: Post-procedure angiogram final residual stenosis <30%
Timepoint [2] 324211 0
Post procedure angiogram is performed intraoperatively, after angioplasty +/- high-pressure balloon if device failure +/- stent in case of flow-limiting dissection or rupture.
Secondary outcome [3] 324212 0
Clinical success (smooth haemodialysis for 3 consecutive sessions)
Timepoint [3] 324212 0
1-2 week post intervention

Eligibility
Key inclusion criteria
Native arteriovenous fistula or prosthetic arteriovenous graft in the upper limb
Vascular access actively used for hemodialysis
At least 1 previous successful session of hemodialysis via access
Clinical signs of failing access due to presence of significant anatomic stenosis
Detection of elevated venous pressure during dialysis and/or decreased blood flow
Angiographically/sonographically proven venous outflow stenosis >50%
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient unable to provide informed consent
Patient unable to abide with study follow-up protocol
Patient participating in other relevant or conflicting studies
Vascular access circuit placed in the lower extremities
Bare metal stent or stent graft placed previously
Hemodynamically significant stenosis of the central venous system
Metastatic malignancy or other terminal medical condition
Limited life expectancy (<6 months)
Blood coagulation disorders
Sepsis or active infection
Recent arm thrombophlebitis (<6 months)
Allergy or other known contraindication to iodinated contrast media, heparin, or paclitaxel
Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Use of sealed opaque envelopes containing computer-generated random numbers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 17 patients per group is required to detect a difference of 25% in patency rate with a power of 80% and a Type I error of 5 %. With the assumption of 10% loss of follow-up in each group, a sample size of 20 patients per group is required.

Data will be analyzed following intention to treat principle.
Primary and secondary outcomes will be reported as relative risk and 95% confidence intervals. Confounding variables will be controlled by logistic regression.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/06/2016
Date of last participant enrolment
Anticipated
25/05/2018
Actual
23/04/2018
Date of last data collection
Anticipated
Actual
16/04/2019
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 7917 0
Hong Kong
State/province [1] 7917 0
Hong Kong

Funding & Sponsors
Funding source category [1] 293692 0
Hospital
Name [1] 293692 0
Department of Surgery, Pamela Youde Nethersole Eastern Hospital, Hong Kong
Country [1] 293692 0
Hong Kong
Primary sponsor type
Hospital
Name
Department of Surgery, Pamela Youde Nethersole Eastern Hospital, Hong Kong
Address
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan,
Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 292525 0
None
Name [1] 292525 0
Address [1] 292525 0
Country [1] 292525 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295129 0
Hong Kong East Cluster Research Ethics Committee
Ethics committee address [1] 295129 0
Ethics committee country [1] 295129 0
Hong Kong
Date submitted for ethics approval [1] 295129 0
14/03/2016
Approval date [1] 295129 0
13/05/2016
Ethics approval number [1] 295129 0
HKEC-2015-098

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 905 905 0 0
/AnzctrAttachments/370794-Protocol DEB RCT.pdf
Attachments [2] 906 906 0 0
/AnzctrAttachments/370794-Approval letter_HKEC-2015-098.pdf
Attachments [3] 907 907 0 0
/AnzctrAttachments/370794-5. Data collection form .pdf
Attachments [4] 908 908 0 0
/AnzctrAttachments/370794-Chinese Info Sheet Consent .pdf
Attachments [5] 909 909 0 0
/AnzctrAttachments/370794-English Info Sheet & Consent.pdf

Contacts
Principal investigator
Name 66234 0
Dr Pang Yin Chun, Skyi
Address 66234 0
Department of Surgery
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chan Wai, Hong Kong
Country 66234 0
Hong Kong
Phone 66234 0
+85264600365
Fax 66234 0
Email 66234 0
pangyc2@ha.org.hk
Contact person for public queries
Name 66235 0
Pang Yin Chun, Skyi
Address 66235 0
Department of Surgery
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chan Wai, Hong Kong
Country 66235 0
Hong Kong
Phone 66235 0
+85264600365
Fax 66235 0
Email 66235 0
pangyc2@ha.org.hk
Contact person for scientific queries
Name 66236 0
Pang Yin Chun, Skyi
Address 66236 0
Department of Surgery
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chan Wai, Hong Kong
Country 66236 0
Hong Kong
Phone 66236 0
+85264600365
Fax 66236 0
Email 66236 0
pangyc2@ha.org.hk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient demographics
When will data be available (start and end dates)?
1/10/2019 to 1/12/2020
Available to whom?
Interested parties
Available for what types of analyses?
to achieve the aims in the approved proposal e.g. meta-analysis / systemic reviews
How or where can data be obtained?
Please contact primary author via email


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.