Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202011880135496 Date of Approval: 12/11/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title DRUG COATED BALLOON ANGIOPLASTY IN FAILING ARTERIOVENOUS GRAFTS IN END STAGE RENAL DISEASE
Official scientific title DRUG COATED BALLOON ANGIOPLASTY IN FAILING ARTERIOVENOUS GRAFTS IN END STAGE RENAL DISEASE
Brief summary describing the background and objectives of the trial In South Africa, state-funded haemodialysis is available for end-stage renal disease through a rationing process. In order to successfully perform haemodialysis, a functional vascular access point is required and this is usually obtained by an arteriovenous graft (AVG). Stenosis and thrombosis in haemodialysis access circuits are a major challenge and lead to access dysfunction. Endovascular approaches for dialysis access management in AVGs include balloon angioplasty and stenting. Drug-coated balloon (DCB) angioplasty has emerged as one of the most effective strategies in preventing stenosis or restenosis after intervention, however, only plain old balloon angioplasty (POBA) is currently being used as treatment for dysfunctional AVGs in the public healthcare sector of South Africa, and patients return with restenosis within six months. Moreover, it is hypothesized that the cost of repeated POBA treatments may exceed that of using DCB angioplasty. In South Africa’s private healthcare sector, POBAs, DCB and stents are used according to the vascular surgeon’s preference, in accordance with the patient’s clinical workup. Nevertheless, in our experience, DCBs significantly improve the outcomes in our dialysis patients when compared to POBA, and stenting is reserved for patients with ≥50% stenosis within the graft. The purpose of this study is to prospectively investigate whether DCB angioplasty of stenotic regions in haemodialysis AVGs has improved outcomes compared to POBA. Apart from consenting adult patients being randomized into either the POBA or DCB group, the study is observational of our routine management for failed AVGs.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) DCBSA
Disease(s) or condition(s) being studied Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 09/11/2020
Actual trial start date
Anticipated date of last follow up 30/06/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Plain Old Balloon Angioplasty POBA No coated drug on balloon. 1 procedure POBA will be conducted within the failing AV graft, as per routine procedures, and balloon length and diameter will be recorded. Only if the balloon fails to pass the stenotic region will pre-dilation be performed. If the % residual stenosis after the initial POBA procedure is ≥50%, these patients will receive a bare-metal stent and default to the stent group, as per routine practice. 60 Active-Treatment of Control Group
Experimental Group Drug coated balloon DCB angioplasty Once off Paclitaxel-coated balloon. 1 procedure. DCB angioplasty will be conducted within the failing AV graft, as per routine procedures, and balloon length and diameter will be recorded. Only if the DCB fails to pass the stenotic region will pre-dilation be performed. If the % residual stenosis after the initial DCB procedure is ≥50%, these patients will receive a bare-metal stent and default to the stent group, as per routine practice. 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All adult haemodialysis patients with dysfunctional AVGs (≥50% stenosis) presenting to the Vascare Rooms located at two private hospitals will be invited to participate in this study. No prior AV graft intervention. AV graft >4 months old. This is to exclude any failed grafts in the initial period following access placement and maturation. AV graft >18 months old. 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/11/2019 University of the Witwatersrand Human Research Ethics Committee Medical
Ethics Committee Address
Street address City Postal code Country
Philip Tobias Building, York Road, Parktown Johannesburg 2193 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/11/2019 Private Hospital Healthcare Group A
Ethics Committee Address
Street address City Postal code Country
Ilovo Johannesburg 2196 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 29/10/2019 Private Hospital Group B
Ethics Committee Address
Street address City Postal code Country
Sandton Johannesburg 2010 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Primary patency of haemodialysis AVGs following POBA vs DCB (primary endpoint). Procedure day
Secondary Outcome 2. To compare the % restenosis and/or primary assisted patency post-DCB angioplasty to post-POBA at 6 weeks (±1 week) (secondary endpoint). 3. To compare the % restenosis and/or primary assisted patency* post-DCB angioplasty to post-POBA at 6 months (180 days; ±30 days) (secondary endpoint). 6 weeks and 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Private Hospital B Sunninghill Sandton 2196 South Africa
Private Hospital A Fourways Johannesburg 2055 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Medtronic External Research Program 3033 Campus Drive Plymouth MINNESOTA 55441 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of the Witwatersrand and PI Prof Deirdre Kruger 7 York Road, Parktown Johannesburg 2193 South Africa University
Primary Sponsor Vascare Rooms Drs Dirk Le Roux and Pradeep Mistry Private Hospital A and Private Hospital B Johannesburg 2196 South Africa Other Collaborative Groups
COLLABORATORS
Name Street address City Postal code Country
Ms Mellisa Mabhikwa 7 York Road Johannesburg 2193 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Deirdre Kruger Deirdre.Kruger@wits.ac.za +27117172376 7 York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Head of Research and Laboratories Department of Surgery Wits University
Role Name Email Phone Street address
Principal Investigator Dirk Le Roux leroux@vascare.co.za +27824526213 Witkoppen Rd and Nanyuki Road, Sunninghill
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa Consultant Vascular Surgeon
Role Name Email Phone Street address
Principal Investigator Pradeep Mistry mistry@vascare.co.za +27824169863 Witkoppen Road and Nanyuki Road, Sunninghill
City Postal code Country Position/Affiliation
Johannesburg 2196 South Africa Consultant Vascular Surgeon
Role Name Email Phone Street address
Public Enquiries Mellisa Mabhikwa melmbk@gmail.com +27740212418 7 York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Data capturer Study coordinator
Role Name Email Phone Street address
Scientific Enquiries Deirdre Kruger Deirdre.Kruger@wits.ac.za +27117172376 7 York Road, Parktown
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Head of Research Department of Surgery WITS University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The summary of results or a link to summary results will be submitted within 12 months of the study completion date. Informed Consent Form,Study Protocol 2 years Controlled data access ultimately decided by the HREC of the University of the Witwatersrand. Data will be analyzed by the PI (D Kruger) and collaborator (M Mabhikwa - MSc Biostatistician).
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information