Neointimal HyperplasiaPREDATORNCT05360394
A Prospective, Randomized Controlled Trial of Stent Graft and Drug Coated Balloon Treatment for Recurrent Cephalic Arch Stenosis in Dysfunctional Arteriovenous-venous Fistula
A study testing Paclitaxel Coated Balloon and Paclitaxel Coated Balloon and Stent Graft in people with Neointimal Hyperplasia and Dialysis Access Malfunction, run by Singapore General Hospital at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Neointimal Hyperplasia, Dialysis Access Malfunction
- What is being tested?
- Paclitaxel Coated Balloon and Paclitaxel Coated Balloon and Stent Graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Apr 2022to Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Australia1 site, 1 recruiting
- Recruiting
Flinders Medical Center
Adelaide, 5042
Chris Delaney, 0882045445
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169856
Charyl Yap, 6576 7986, Charyl.yap.j.q@sgh.com.sg
About this study
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.
Read more
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.
- Being tested
- Paclitaxel Coated Balloon, Paclitaxel Coated Balloon and Stent Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel Coated BalloonDevice
CAS treated with PCB only
Paclitaxel Coated Balloon and Stent GraftDevice
CAS treated with PCB first before deployment of stent graft
| Study group | Role | What they receive |
|---|---|---|
| PCB Only | Active comparator | Cephalic arch stenosis is first treated with conventional plain balloon angioplasty. Once treated adequately (<30% residual stenosis), CAS will be treated with PCB angioplasty. Receives: Device: Paclitaxel Coated Balloon |
| Stent Graft and PCB angioplasty of stent edges | Experimental | 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. Receives: Device: Paclitaxel Coated Balloon and Stent Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Patency of Target Lesion (Cepahlic Arch)
Freedom from any re-intervention at target lesion that is clinically driven or indicated on surveillance scan
Measured: 6-months post-op
Primary Patency of Access Circuit
Percentage of patients who do not need to undergo another re-intervention at the dialysis access circuit
Measured: 6-months post-op
Secondary outcomes (10)
Primary Patency of Target Lesion
Percentage of patients who do not need to undergo another re-intervention at the target lesion
Measured: 3 and 12 months post-op
Primary Patency of Access Circuit
Freedom from any re-intervention that is clinically driven or indicated on surveillance scan
Measured: 3 and 12 months post-op
Assisted Primary Patency of Target Lesion
Percentage of patients who do not need to undergo another thrombolysis or thrombectomy at target lesion.
Measured: 3 and 12 months post-op
Assisted Primary Patency of Access Circuit
Percentage of patients who do not need to undergo another thrombolysis or thrombectomy at dialysis access circuit
Measured: 3 and 12 months post-op
Secondary Patency
Percentage of patients who will not need creation of a new AVF or an alternative dialysis access site.
Measured: 3 and 12 months post-op
Time taken to next intervention
Measured: 12-months post-op
Number of repeat interventions to target lesion
Measured: 6 and 12 months post-op
Number of repeat interventions to maintain access circuit
Measured: 6 and 12 months post-op
Rate of late lumen loss of the cephalic arch, proximal and distal stent edge
Measured: 12 months post-op
Complication Rate
Measured: 1, 3, 6 and 12 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2022
- Study start20 Apr 2022
- Primary completionOct 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Neointimal HyperplasiaStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tang Tjun Yip, Principal investigator, Singapore General HospitalTan Ru Yu, Principal investigator, Singapore General HospitalTay Kiang Hiong, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05360394
- Sponsor's protocol ID
- 2021/2044
- Acronym
- PREDATOR
- Status last verified
- Apr 2022
- First submitted
- 26 Apr 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16565259Rajan 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.
PubMed 12761309Trerotola 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.
PubMed 33975757Irani 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.
PubMed 30040057Swinnen 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.
PubMed 30227772Shemesh 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.
PubMed 18829240Rajan 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.
PubMed 26074027Ginsburg 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.
PubMed 26038628
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Trial of Stent Graft and Drug Coated Balloon Treatment for Recurrent Cephalic Arch Stenosis in Dysfunctional Arteriovenous-venous Fistula
- ClinicalTrials.gov ID
- NCT05360394
- Acronym / sponsor ID
- PREDATOR / 2021/2044
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 4 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCB Only | Active comparator | Device: Paclitaxel Coated BalloonCephalic arch stenosis is first treated with conventional plain balloon angioplasty. Once treated adequately (<30% residual stenosis), CAS will be treated with PCB angioplasty. |
| Stent Graft and PCB angioplasty of stent edges | Experimental | Device: Paclitaxel Coated Balloon and Stent GraftCAS 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. |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel Coated BalloonCAS treated with PCB only | Device | PCB Only |
| Paclitaxel Coated Balloon and Stent GraftCAS treated with PCB first before deployment of stent graft | Device | Stent Graft and PCB angioplasty of stent edges |
Primary outcome
Primary Patency of Target Lesion (Cepahlic Arch)
Time frame: 6-months post-op
Freedom from any re-intervention at target lesion that is clinically driven or indicated on surveillance scan
Primary Patency of Access Circuit
Time frame: 6-months post-op
Percentage of patients who do not need to undergo another re-intervention at the dialysis access circuit
10 secondary outcomes
Primary Patency of Target Lesion
Time frame: 3 and 12 months post-op
Primary Patency of Access Circuit
Time frame: 3 and 12 months post-op
Assisted Primary Patency of Target Lesion
Time frame: 3 and 12 months post-op
Assisted Primary Patency of Access Circuit
Time frame: 3 and 12 months post-op
Secondary Patency
Time frame: 3 and 12 months post-op
Time taken to next intervention
Time frame: 12-months post-op
Number of repeat interventions to target lesion
Time frame: 6 and 12 months post-op
Number of repeat interventions to maintain access circuit
Time frame: 6 and 12 months post-op
Rate of late lumen loss of the cephalic arch, proximal and distal stent edge
Time frame: 12 months post-op
Complication Rate
Time frame: 1, 3, 6 and 12 months post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
- Background: PubMed 16565259Roy-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.
- Background: PubMed 12761309Rajan 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.
- Background: PubMed 33975757Trerotola 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.
- Background: PubMed 30040057Irani 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.
- Background: PubMed 30227772Swinnen 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.
- Background: PubMed 18829240Shemesh 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.
- Background: PubMed 26074027Rajan 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.
- Background: PubMed 26038628Ginsburg 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tang Tjun Yip principal investigator
Singapore General Hospital
Tan Ru Yu principal investigator
Singapore General Hospital
Tay Kiang Hiong principal investigator
Singapore General Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paclitaxel Coated Balloon and Paclitaxel Coated Balloon and Stent Graft in people with Neointimal Hyperplasia and Dialysis Access Malfunction, run by Singapore General Hospital at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charyl Yap (6576 7986, Charyl.yap.j.q@sgh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Patency of Target Lesion (Cepahlic Arch) (time frame: 6-months post-op). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05360394, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.