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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05360394




Registration number
NCT05360394
Ethics application status
Date submitted
26/04/2022
Date registered
4/05/2022

Titles & IDs
Public title
A Prospective, Randomized Controlled Trial of Stent Graft and Drug Coated Balloon Treatment for Recurrent Cephalic Arch Stenosis in Dysfunctional Arteriovenous-venous Fistula
Scientific title
A Prospective, Randomized Controlled Trial of Stent Graft and Drug Coated Balloon Treatment for Recurrent Cephalic Arch Stenosis in Dysfunctional Arteriovenous-venous Fistula
Secondary ID [1] 0 0
2021/2044
Universal Trial Number (UTN)
Trial acronym
PREDATOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neointimal Hyperplasia 0 0
Dialysis Access Malfunction 0 0
Condition category
Condition code
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Paclitaxel Coated Balloon
Treatment: Devices - Paclitaxel Coated Balloon and Stent Graft

Active comparator: PCB Only - Cephalic arch stenosis is first treated with conventional plain balloon angioplasty. Once treated adequately (\<30% residual stenosis), CAS will be treated with PCB angioplasty.

Experimental: Stent Graft and PCB angioplasty of stent edges - CAS is first treated with conventional plain balloon angioplasty. Once treated adequately (\<30% residual stenosis), CAS will be treated with PCB first to avoid geographical miss. After which, stent graft will be deployed. Length of PCB shall be long enough to cover stent edges.


Treatment: Devices: Paclitaxel Coated Balloon
CAS treated with PCB only

Treatment: Devices: Paclitaxel Coated Balloon and Stent Graft
CAS treated with PCB first before deployment of stent graft
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Patency of Target Lesion (Cepahlic Arch)
Timepoint [1] 0 0
6-months post-op
Primary outcome [2] 0 0
Primary Patency of Access Circuit
Timepoint [2] 0 0
6-months post-op
Secondary outcome [1] 0 0
Primary Patency of Target Lesion
Timepoint [1] 0 0
3 and 12 months post-op
Secondary outcome [2] 0 0
Primary Patency of Access Circuit
Timepoint [2] 0 0
3 and 12 months post-op
Secondary outcome [3] 0 0
Assisted Primary Patency of Target Lesion
Timepoint [3] 0 0
3 and 12 months post-op
Secondary outcome [4] 0 0
Assisted Primary Patency of Access Circuit
Timepoint [4] 0 0
3 and 12 months post-op
Secondary outcome [5] 0 0
Secondary Patency
Timepoint [5] 0 0
3 and 12 months post-op
Secondary outcome [6] 0 0
Time taken to next intervention
Timepoint [6] 0 0
12-months post-op
Secondary outcome [7] 0 0
Number of repeat interventions to target lesion
Timepoint [7] 0 0
6 and 12 months post-op
Secondary outcome [8] 0 0
Number of repeat interventions to maintain access circuit
Timepoint [8] 0 0
6 and 12 months post-op
Secondary outcome [9] 0 0
Rate of late lumen loss of the cephalic arch, proximal and distal stent edge
Timepoint [9] 0 0
12 months post-op
Secondary outcome [10] 0 0
Complication Rate
Timepoint [10] 0 0
1, 3, 6 and 12 months post-op

Eligibility
Key inclusion criteria
* Age 21 - 90 years
* Patients who requires balloon angioplasty for dysfunctional arteriovenous fistula, can be de novo lesions or recurrent CAS stenosis within six months of interventions. Suitability will be determined with a baseline ultrasound assessment.
* Matured AVF, defined as being in use for at least 1 month prior to angioplasty
* Successful angioplasty of the underlying stenosis, defined as less than 30% residual stenosis on Digital Subtraction Angiography (DSA).
Minimum age
21 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient unable to provide informed consent
* Thrombosed or partially thrombosed AVF
* Immature AVF
* Insignificant CAS defined as <50% stenosis and no clinical indicator such as high V pressure.
* Presence of central vein stenosis with more than 30% residual stenosis post-angioplasty
* Patient who had underwent stent placement within the CAS previously
* Patients who are allergic to both aspirin or clopidogrel
* Patient who are currently enrolled in other drug eluting balloon trials
* Sepsis or active infection
* Recent intracranial bleed or gastrointestinal bleed within the past 12 months.
* Allergy 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Center - Adelaide
Recruitment postcode(s) [1] 0 0
5042 - Adelaide
Recruitment outside Australia
Country [1] 0 0
Singapore
State/province [1] 0 0
Singapore

Funding & Sponsors
Primary sponsor type
Other
Name
Singapore General Hospital
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Tang Tjun Yip
Address 0 0
Singapore General Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Charyl Yap
Address 0 0
Country 0 0
Phone 0 0
6576 7986
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05360394