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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05360394




Registration number
NCT05360394
Ethics application status
Date submitted
26/04/2022
Date registered
4/05/2022
Date last updated
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
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
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
Arteriovenous Fistula (AVF) is a surgically created circuit used for hemodialysis in patient
with End Stage Renal Disease (ESRD). A functioning dialysis vascular access is critical to
the delivery of life-saving hemodialysis (HD) treatment for these patients. Unfortunately,
neointimal hyperplasia frequently occurs within the dialysis vascular access, resulting in
stenosis, poor flow and thrombosis with loss of function.

The cephalic vein forms the outflow conduit for radiocephalic (RC) and brachiocephalic (BC)
AVF. At the perpendicular portion of the cephalic vein, the cephalic arch is often prone to
developing hemodynamically significant stenosis. The prevalence of cephalic arch stenosis is
reported to be 39% in brachiocepahlic and 2% in radiocephalic AVF.

The current gold standard therapy for treatment of AVF stenosis is plain balloon angioplasty
(BA). Paclitaxel coated balloon (PCB) angioplasty has also been shown recently to be superior
to plain BA in the treatment of stenosis in dialysis vascular access. By releasing
paclitaxel, which is an anti-proliferation drug, locally into the vessel wall during balloon
contact, it will blunt the acceleration of intimal hyperplasia response, resulting in
improved primary patency after angioplasty.

The use of stent grafts for recurrent CAS has been demonstrated to increase patency of AVF
compared to BA and bare stents. However, stent grafts are prone to edge restenosis that tend
to occur within 5mm of each end of SG due to neointimal hyperplasia from the end of the stent
migrating towards the center. We postulate that stent graft with PCB angioplasty of the stent
edge is more effective than PCB alone in maintaining the patency of AVF with cephalic arch
stenosis.

Therefore, we aim to perform a randomized controlled trial to compare the 6-month unassisted
patency rate of treatment of recurrent CAS with stent graft and PCB angioplasty of both stent
edge versus PCB alone.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05360394
Trial related presentations / publications
Roy-Chaudhury P, Sukhatme VP, Cheung AK. Hemodialysis vascular access dysfunction: a cellular and molecular viewpoint. J Am Soc Nephrol. 2006 Apr;17(4):1112-27. doi: 10.1681/ASN.2005050615.
Rajan DK, Clark TW, Patel NK, Stavropoulos SW, Simons ME. Prevalence and treatment of cephalic arch stenosis in dysfunctional autogenous hemodialysis fistulas. J Vasc Interv Radiol. 2003 May;14(5):567-73. doi: 10.1097/01.rvi.0000071090.76348.bc.
Trerotola SO, Roy-Chaudhury P, Saad TF. Drug-Coated Balloon Angioplasty in Failing Arteriovenous Fistulas: More Data, Less Clarity. Am J Kidney Dis. 2021 Jul;78(1):13-15. doi: 10.1053/j.ajkd.2021.02.331. Epub 2021 May 8. No abstract available.
Irani FG, Teo TKB, Tay KH, Yin WH, Win HH, Gogna A, Patel A, Too CW, Chan SXJM, Lo RHG, Toh LHW, Chng SP, Choong HL, Tan BS. Hemodialysis Arteriovenous Fistula and Graft Stenoses: Randomized Trial Comparing Drug-eluting Balloon Angioplasty with Conventional Angioplasty. Radiology. 2018 Oct;289(1):238-247. doi: 10.1148/radiol.2018170806. Epub 2018 Jul 24.
Swinnen JJ, Hitos K, Kairaitis L, Gruenewald S, Larcos G, Farlow D, Huber D, Cassorla G, Leo C, Villalba LM, Allen R, Niknam F, Burgess D. Multicentre, randomised, blinded, control trial of drug-eluting balloon vs Sham in recurrent native dialysis fistula stenoses. J Vasc Access. 2019 May;20(3):260-269. doi: 10.1177/1129729818801556. Epub 2018 Sep 18.
Shemesh D, Goldin I, Zaghal I, Berlowitz D, Raveh D, Olsha O. Angioplasty with stent graft versus bare stent for recurrent cephalic arch stenosis in autogenous arteriovenous access for hemodialysis: a prospective randomized clinical trial. J Vasc Surg. 2008 Dec;48(6):1524-31, 1531.e1-2. doi: 10.1016/j.jvs.2008.07.071. Epub 2008 Oct 1.
Rajan DK, Falk A. A Randomized Prospective Study Comparing Outcomes of Angioplasty versus VIABAHN Stent-Graft Placement for Cephalic Arch Stenosis in Dysfunctional Hemodialysis Accesses. J Vasc Interv Radiol. 2015 Sep;26(9):1355-61. doi: 10.1016/j.jvir.2015.05.001.
Ginsburg M, Lorenz JM, Zivin SP, Zangan S, Martinez D. A practical review of the use of stents for the maintenance of hemodialysis access. Semin Intervent Radiol. 2015 Jun;32(2):217-24. doi: 10.1055/s-0035-1549844. No abstract available.
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
Charyl.yap.j.q@sgh.com.sg
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05360394