Arteriovenous FistulaISABELLANCT04629118
Intervention With Selution SLR™ Agent Balloon for Endovascular Latent Limus Therapy for Failing AV Fistulas (ISABELLA) Trial
An observational study of Arteriovenous Fistula and Dialysis Access Malfunction, run by Singapore General Hospital at 1 site in Singapore.
Trial summary
The most common problem with haemodialysis arteriovenous fistulas (AVF) and arterio-venous grafts (AVG) is stenosis, which can lead to inadequate dialysis, and eventual access thrombosis. Conventional plain old balloon angioplasty (CBA) is associated with high recurrence rates of stenosis and repeated interventions. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Arteriovenous Fistula, Dialysis Access Malfunction
- What is being tested?
- Selution SLR™ 018 Drug Eluting Balloon
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteSingapore
- Study dates
- 27 Oct 2020to 30 Oct 2023
- Phase
- Observational
- 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
Study population: 40 patients with failing dialysis access treated with SELUTION SLR and meet inclusion/exclusion criteria will be enrolled for study
Who may be able to join
- Patient aged ≥21 years and ≤90 years
- Native AVF was created more than 2 months prior to the index procedure and had undergone 10 or more haemodialysis sessions utilising two needles
- Target lesion location has to be located between the anastomoses to the auxiliary-subclavian vein junction, as defined by insertion of the cephalopods vein
- On initial fistulogram, target lesion stenosis has to be >50% on angiographic assessment and in keeping with the clinical indicator for intervention
- Stenosis had to be < 12cm in length (to allow for potential treatment with one DEB (length 15cm) only)
- Stenosis had to be initially treated successfully with a high-pressure plain balloon prior to DEB treatment as defined by:- (A) No clinically significant dissection (flow limiting) (B) No extravasated requiring treatment/Stenting (C) Residual stenosis ≤30% by angiographic measurement (D) Ability to completely efface the lesion waist using the pre-dilation CBA
- No more than one additional ("non-target") lesion in the access circuit that had to be also successfully treated (≤30% residual stenosis) before drug elation. Separate lesion was defined by at least 3cm in distance from the target lesion
- Reference vessel diameters allowed are 4mm - 7mm
Who cannot join
- Women who are pregnant, lactating or planning on becoming pregnant during study
- Subject has more than two lesions in the access circuit
- Subject had a secondary non-target lesion that could not be successfully treated
- Sepsis or active infection
- Asymptomatic target lesions
- A thrombosis access or an access with thrombosis treated ≤30 days prior to the index procedure
Show all 18Show fewer
- Pseudoaneurysm in proposed target lesion area
- Surgical revision of the access site performed, planned or expected ≤3 months before or after the index procedure
- Patients who is taking immunosuppressive therapy or are routinely taking ≥15mg of prednisone per day
- Currently participating in another investigational drug, biologic, or device study involving Sirolimus or Paclitaxel
- Contraindication to aspirin or clopidogrel usage
- Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study, or language barrier such that the subject is unable to give informed consent.
- Uncooperative attitude or potential for non-compliance with the requirements of the protocol making study participation impractical
- Where final angioplasty treatment requires a stent or drug eluting balloon >8mm in diameter
- Metastatic cancer or terminal medical condition
- Blood coagulation disorders
- Limited life expectancy (<12 months)
- Allergy or other known contraindication to iodinated media contrast, heparin, or Sirolimus
Trial locations and contacts
1 site in 1 country.
About this study
The most common problem with haemodialysis arteriovenous fistulas (AVF) and arterio-venous grafts (AVG) is stenosis, which can lead to inadequate dialysis, and eventual access thrombosis. Conventional plain old balloon angioplasty (CBA) is associated with high recurrence rates of stenosis and repeated interventions. The advent of successful drug-eluting technology in the treatment of the coronary vascular bed and subsequent positive accumulating evidence in the peripheral arterial circulation has prompted the use of drug coated balloons (DCB) in the access fistula circuit for venous stenosis and in-stent restenosis. Recent studies suggest that DCBs may significantly reduce re-intervention rates on native and recurrent lesions. The restenosis process is in part or in whole the result of neo-intimal hyperplasia (NIH) and NIH is considered the main culprit in access circuit target lesion stenosis. NIH is the blood vessel's healing response to the barotrauma from the angioplasty process. A critical component of NIH is the cellular proliferative stage with mononuclear leucocytes identified as the primary inflammatory cell type involved. The rationale for drug elution is to block the NIH response with an anti-metabolite such as paclitaxel. It is important to emphasize that the role of drug elution in the treatment of vascular stenosis is not to obtain a good haemodynamic and luminal result but to preserve a good result obtained during POBA from later restenosis due to NIH and minimise reinterventions and readmissions to hospital for what is a frail population of patients.
A meta-analysis performed by Khawaja et al. seemed to suggest that DCBs conferred some benefit in terms of improving target lesion primary patency (TLPP) in AVFs. An updated meta-analysis performed by our own institution recently reinforced that DCB appears to be a better and safe alternative to CBA in treating patients with stenosis within all haemodialysis circuits (fistulas and grafts) based on 6- and 12-months primary patency and increased intervention free period 5. However, this was not reflected in the largest RCT to date of DCB vs CBA in AVF with no superior target lesion patency demonstrated at six months and one and two years follow-up. Another recent meta-analysis found paclitaxel-coated balloons (PCB) showed no statistically significant improvement over conventional balloons in decreasing fistula stenosis in randomized controlled trials but were significant for cohort studies. Hence this shows the heterogeneity of the available data in the literature and the result is dependent on what studies you include in the review. Another reason why the outcome data is variable is that the high-speed blood flow in dialysis access circuits washes a large amount of the paclitaxel away from the target lesion soon after application. A measurement in swine showed that only 20%-30% of paclitaxel was taken up into the coronary artery wall in vivo 15-25minutes after PCB application.
Furthermore, recent attention has been drawn to a possible increase in late mortality signal and lower amputation free survival in patients receiving DCB treatment with paclitaxel for peripheral arterial disease, although this suggestion has not been demonstrated in the data of DCB within the fistula circuit either at 1 or 2 years. In light of these concerns, attention has turned away recently from paclitaxel-based technologies to sirolimus coated platforms. Sirolimus, like paclitaxel, is a potent antiproliferative agent, which has been found to prevent restenosis in the coronary bed and more recently in the peripheral vasculature but to date has not been studied in AVF circuits The aims of the study is to determine the safety and efficacy of the MedAlliance SELUTION SLR 018™ DEB in the treatment of failing AV fistula due to conduit stenosis in patients undergoing renal dialysis.
- Conditions
- Arteriovenous Fistula, Dialysis Access Malfunction
- Being tested
- Selution SLR™ 018 Drug Eluting Balloon
- Keywords
- Drug-Coated Balloons, Sirolimus, Arteriovenous Fistula, Fistuloplasty
- Medical subject headings
- Arteriovenous Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selution SLR™ 018 Drug Eluting BalloonDevice
Also called Sirolimus DEB
Target lesion will be pre-dilated with high pressure non-compliant balloon, then treated with SELUTION SLR™ 018 DEB Balloon.
| Study group | Role | What they receive |
|---|---|---|
| Selution SLR™ 018 Drug Eluting Balloon | Subjects will undergo fistuloplasty with the study device - Selution SLR™ 018 Drug Eluting Balloon Receives: Device: Selution SLR™ 018 Drug Eluting Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Primary Patency
Defined as patency with no re-intervention to the area treated by SELUTION SLR™ DEB and a duplex-defined stenosis within the index-treated segment of <50%. TLPP ends when any of the following occur:- 1) clinically driven re-intervention to the treated segment, 2) thrombotic occlusions that includes the treatment segment, 3) surgical intervention that excludes the treatment segment from the access circuit, 4) abandonment of the AVF due to an inability to treat the target lesion, 5) duplex finding of more than 50% stenosis.
Measured: 6 months post-index procedure
Freedom from adverse events
Freedom from events including thrombosis, life-threatening events or those resulting in death, requiring hospitalisation, resulting in permanent disability, requiring intervention to prevent permanent impairment.
Measured: 30 days post-index procedure
Secondary outcomes (10)
Freedom from any serious adverse event(s) involving the AV access circuit or the patient
Measured: 3 and 6 months post-index procedure
Target Lesion Primary Patency and Access circuit primary patency
Defined as patency with no re-intervention to the area treated by SELUTION SLR™ DEB and a duplex-defined stenosis within the index-treated segment of <50%. TLPP ends when any of the following occur:- 1) clinically driven re-intervention to the treated segment, 2) thrombotic occlusions that includes the treatment segment, 3) surgical intervention that excludes the treatment segment from the access circuit, 4) abandonment of the AVF due to an inability to treat the target lesion, 5) duplex finding of more than 50% stenosis.
Measured: 3 months post index procedure
Device Success
Successful balloon inflation of the SELUTION catheter for more than 2 minutes and retrieval of the catheter
Measured: Intra-operative
Anatomical Success
<30% residual stenosis diameter measured immediately after an angioplasty
Measured: Immediately post-op
Clinical Success
Improvement from baseline in the clinical or hemodynamic parameter (e.g. blood flow, venous pressure) that was the initial indicator of fistula dysfunction and the resumption of normal hemodialysis for a minimum of at least 1 session following the procedure
Measured: 1 week post-index procedure
Need for open revision surgery
Measured: 2 years post-index procedure
Secondary patency
Interval after intervention until access circuit is abandoned, including reinterventions to reestablish access flow.
Measured: 3 months and 6 months post-index procedure
Access circuit thrombosis
Measured: 2 years post-index procedure
Number of interventions required to maintain access circuit patency
Measured: 3 and 6 months post-index procedure
Mortality rate
Measured: 3 and 6 months post-index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start27 Oct 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Arteriovenous FistulaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tjun Yip Tang, Principal investigator, Singapore General HospitalTze Tec Chong, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629118
- Sponsor's protocol ID
- 2020/2782
- Acronym
- ISABELLA
- Status last verified
- Sep 2021
- First submitted
- 8 Nov 2020
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Troisi N, Frosini P, Somma C, Romano E, Guidotti A, Dattolo PC, Ferro G, Chisci E, Michelagnoli S. Drug-coated balloons reduce the risk of recurrent restenosis in arteriovenous fistulas and prosthetic grafts for hemodialysis. Int Angiol. 2018 Feb;37(1):59-63. doi: 10.23736/S0392-9590.17.03886-X. Epub 2017 Nov 10.
PubMed 29125264Kennedy SA, Mafeld S, Baerlocher MO, Jaberi A, Rajan DK. Drug-Coated Balloon Angioplasty in Hemodialysis Circuits: A Systematic Review and Meta-Analysis. J Vasc Interv Radiol. 2019 Apr;30(4):483-494.e1. doi: 10.1016/j.jvir.2019.01.012. Epub 2019 Mar 8.
PubMed 30857987Roy-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 16565259Khawaja AZ, Cassidy DB, Al Shakarchi J, McGrogan DG, Inston NG, Jones RG. Systematic review of drug eluting balloon angioplasty for arteriovenous haemodialysis access stenosis. J Vasc Access. 2016 Mar-Apr;17(2):103-10. doi: 10.5301/jva.5000508. Epub 2016 Feb 5.
PubMed 26847736Trerotola SO, Saad TF, Roy-Chaudhury P; Lutonix AV Clinical Trial Investigators. The Lutonix AV Randomized Trial of Paclitaxel-Coated Balloons in Arteriovenous Fistula Stenosis: 2-Year Results and Subgroup Analysis. J Vasc Interv Radiol. 2020 Jan;31(1):1-14.e5. doi: 10.1016/j.jvir.2019.08.035. Epub 2019 Nov 6.
PubMed 31706886Abdul Salim S, Tran H, Thongprayoon C, Fulop T, Cheungpasitporn W. Comparison of drug-coated balloon angioplasty versus conventional angioplasty for arteriovenous fistula stenosis: Systematic review and meta-analysis. J Vasc Access. 2020 May;21(3):357-365. doi: 10.1177/1129729819878612. Epub 2019 Oct 9.
PubMed 31595799Kelsch B, Scheller B, Biedermann M, Clever YP, Schaffner S, Mahnkopf D, Speck U, Cremers B. Dose response to Paclitaxel-coated balloon catheters in the porcine coronary overstretch and stent implantation model. Invest Radiol. 2011 Apr;46(4):255-63. doi: 10.1097/RLI.0b013e31820577df.
PubMed 21285890Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2018 Dec 18;7(24):e011245. doi: 10.1161/JAHA.118.011245.
PubMed 30561254Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Paraskevopoulos I, Karnabatidis D. Risk of Death and Amputation with Use of Paclitaxel-Coated Balloons in the Infrapopliteal Arteries for Treatment of Critical Limb Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Vasc Interv Radiol. 2020 Feb;31(2):202-212. doi: 10.1016/j.jvir.2019.11.015. Epub 2020 Jan 15.
PubMed 31954604Cao Z, Li J, Zhang T, Zhao K, Zhao J, Yang Y, Jiang C, Zhu R, Li Z, Wu W. Comparative Effectiveness of Drug-Coated Balloon vs Balloon Angioplasty for the Treatment of Arteriovenous Fistula Stenosis: A Meta-analysis. J Endovasc Ther. 2020 Apr;27(2):266-275. doi: 10.1177/1526602820902757. Epub 2020 Feb 11.
PubMed 32043432Tang TY, Choke EC, Walsh SR, Tiwari A, Chong TT. What Now for the Endovascular Community After the Paclitaxel Mortality Meta-Analysis: Can Sirolimus Replace Paclitaxel in the Peripheral Vasculature? J Endovasc Ther. 2020 Feb;27(1):153-156. doi: 10.1177/1526602819881156. Epub 2019 Oct 14. No abstract available.
PubMed 31608741Ali RM, Abdul Kader MASK, Wan Ahmad WA, Ong TK, Liew HB, Omar AF, Mahmood Zuhdi AS, Nuruddin AA, Schnorr B, Scheller B. Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2019 Mar 25;12(6):558-566. doi: 10.1016/j.jcin.2018.11.040.
PubMed 30898253Tang TY. How Low Can You Go? SELUTION SLR™ Tibial Artery Drug-Coated Balloon Angioplasty in the Setting of CLTI Conference Proceedings 2020; Leipzig Interventional Course (LINC), Leipzig, Germany
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention With Selution SLR™ Agent Balloon for Endovascular Latent Limus Therapy for Failing AV Fistulas (ISABELLA) Trial
- ClinicalTrials.gov ID
- NCT04629118
- Acronym / sponsor ID
- ISABELLA / 2020/2782
- Conditions
- Arteriovenous Fistula, Dialysis Access Malfunction
- Keywords
- Drug-Coated Balloons, Sirolimus, Arteriovenous Fistula, Fistuloplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 27 Oct 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 16 Nov 2020 (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.
The most common problem with haemodialysis arteriovenous fistulas (AVF) and arterio-venous grafts (AVG) is stenosis, which can lead to inadequate dialysis, and eventual access thrombosis. Conventional plain old balloon angioplasty (CBA) is associated with high recurrence rates of stenosis and repeated interventions. The advent of successful drug-eluting technology in the treatment of the coronary vascular bed and subsequent positive accumulating evidence in the peripheral arterial circulation has prompted the use of drug coated balloons (DCB) in the access fistula circuit for venous stenosis and in-stent restenosis. Recent studies suggest that DCBs may significantly reduce re-intervention rates on native and recurrent lesions. The restenosis process is in part or in whole the result of neo-intimal hyperplasia (NIH) and NIH is considered the main culprit in access circuit target lesion stenosis. NIH is the blood vessel's healing response to the barotrauma from the angioplasty process. A critical component of NIH is the cellular proliferative stage with mononuclear leucocytes identified as the primary inflammatory cell type involved. The rationale for drug elution is to block the NIH response with an anti-metabolite such as paclitaxel. It is important to emphasize that the role of drug elution in the treatment of vascular stenosis is not to obtain a good haemodynamic and luminal result but to preserve a good result obtained during POBA from later restenosis due to NIH and minimise reinterventions and readmissions to hospital for what is a frail population of patients.
A meta-analysis performed by Khawaja et al. seemed to suggest that DCBs conferred some benefit in terms of improving target lesion primary patency (TLPP) in AVFs. An updated meta-analysis performed by our own institution recently reinforced that DCB appears to be a better and safe alternative to CBA in treating patients with stenosis within all haemodialysis circuits (fistulas and grafts) based on 6- and 12-months primary patency and increased intervention free period 5. However, this was not reflected in the largest RCT to date of DCB vs CBA in AVF with no superior target lesion patency demonstrated at six months and one and two years follow-up. Another recent meta-analysis found paclitaxel-coated balloons (PCB) showed no statistically significant improvement over conventional balloons in decreasing fistula stenosis in randomized controlled trials but were significant for cohort studies. Hence this shows the heterogeneity of the available data in the literature and the result is dependent on what studies you include in the review. Another reason why the outcome data is variable is that the high-speed blood flow in dialysis access circuits washes a large amount of the paclitaxel away from the target lesion soon after application. A measurement in swine showed that only 20%-30% of paclitaxel was taken up into the coronary artery wall in vivo 15-25minutes after PCB application.
Furthermore, recent attention has been drawn to a possible increase in late mortality signal and lower amputation free survival in patients receiving DCB treatment with paclitaxel for peripheral arterial disease, although this suggestion has not been demonstrated in the data of DCB within the fistula circuit either at 1 or 2 years. In light of these concerns, attention has turned away recently from paclitaxel-based technologies to sirolimus coated platforms. Sirolimus, like paclitaxel, is a potent antiproliferative agent, which has been found to prevent restenosis in the coronary bed and more recently in the peripheral vasculature but to date has not been studied in AVF circuits The aims of the study is to determine the safety and efficacy of the MedAlliance SELUTION SLR 018™ DEB in the treatment of failing AV fistula due to conduit stenosis in patients undergoing renal dialysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Selution SLR™ 018 Drug Eluting Balloon | – | Device: Selution SLR™ 018 Drug Eluting BalloonSubjects will undergo fistuloplasty with the study device - Selution SLR™ 018 Drug Eluting Balloon |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 patients with failing dialysis access treated with SELUTION SLR and meet inclusion/exclusion criteria will be enrolled for study
Key inclusion criteria (8 listed)
- Patient aged ≥21 years and ≤90 years
- Native AVF was created more than 2 months prior to the index procedure and had undergone 10 or more haemodialysis sessions utilising two needles
- Target lesion location has to be located between the anastomoses to the auxiliary-subclavian vein junction, as defined by insertion of the cephalopods vein
- On initial fistulogram, target lesion stenosis has to be >50% on angiographic assessment and in keeping with the clinical indicator for intervention
- Stenosis had to be < 12cm in length (to allow for potential treatment with one DEB (length 15cm) only)
Key exclusion criteria (18 listed)
- Women who are pregnant, lactating or planning on becoming pregnant during study
- Subject has more than two lesions in the access circuit
- Subject had a secondary non-target lesion that could not be successfully treated
- Sepsis or active infection
- Asymptomatic target lesions
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 |
|---|---|---|
| Selution SLR™ 018 Drug Eluting BalloonAlso: Sirolimus DEBTarget lesion will be pre-dilated with high pressure non-compliant balloon, then treated with SELUTION SLR™ 018 DEB Balloon. | Device | Selution SLR™ 018 Drug Eluting Balloon |
Primary outcome
Target Lesion Primary Patency
Time frame: 6 months post-index procedure
Defined as patency with no re-intervention to the area treated by SELUTION SLR™ DEB and a duplex-defined stenosis within the index-treated segment of <50%. TLPP ends when any of the following occur:- 1) clinically driven re-intervention to the treated segment, 2) thrombotic occlusions that includes the treatment segment, 3) surgical intervention that excludes the treatment segment from the access circuit, 4) abandonment of the AVF due to an inability to treat the target lesion, 5) duplex finding of more than 50% stenosis.
Freedom from adverse events
Time frame: 30 days post-index procedure
Freedom from events including thrombosis, life-threatening events or those resulting in death, requiring hospitalisation, resulting in permanent disability, requiring intervention to prevent permanent impairment.
10 secondary outcomes
Freedom from any serious adverse event(s) involving the AV access circuit or the patient
Time frame: 3 and 6 months post-index procedure
Target Lesion Primary Patency and Access circuit primary patency
Time frame: 3 months post index procedure
Device Success
Time frame: Intra-operative
Anatomical Success
Time frame: Immediately post-op
Clinical Success
Time frame: 1 week post-index procedure
Need for open revision surgery
Time frame: 2 years post-index procedure
Secondary patency
Time frame: 3 months and 6 months post-index procedure
Access circuit thrombosis
Time frame: 2 years post-index procedure
Number of interventions required to maintain access circuit patency
Time frame: 3 and 6 months post-index procedure
Mortality rate
Time frame: 3 and 6 months post-index procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Background: PubMed 29125264Troisi N, Frosini P, Somma C, Romano E, Guidotti A, Dattolo PC, Ferro G, Chisci E, Michelagnoli S. Drug-coated balloons reduce the risk of recurrent restenosis in arteriovenous fistulas and prosthetic grafts for hemodialysis. Int Angiol. 2018 Feb;37(1):59-63. doi: 10.23736/S0392-9590.17.03886-X. Epub 2017 Nov 10.
- Background: PubMed 30857987Kennedy SA, Mafeld S, Baerlocher MO, Jaberi A, Rajan DK. Drug-Coated Balloon Angioplasty in Hemodialysis Circuits: A Systematic Review and Meta-Analysis. J Vasc Interv Radiol. 2019 Apr;30(4):483-494.e1. doi: 10.1016/j.jvir.2019.01.012. Epub 2019 Mar 8.
- 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 26847736Khawaja AZ, Cassidy DB, Al Shakarchi J, McGrogan DG, Inston NG, Jones RG. Systematic review of drug eluting balloon angioplasty for arteriovenous haemodialysis access stenosis. J Vasc Access. 2016 Mar-Apr;17(2):103-10. doi: 10.5301/jva.5000508. Epub 2016 Feb 5.
- Background: PubMed 31706886Trerotola SO, Saad TF, Roy-Chaudhury P; Lutonix AV Clinical Trial Investigators. The Lutonix AV Randomized Trial of Paclitaxel-Coated Balloons in Arteriovenous Fistula Stenosis: 2-Year Results and Subgroup Analysis. J Vasc Interv Radiol. 2020 Jan;31(1):1-14.e5. doi: 10.1016/j.jvir.2019.08.035. Epub 2019 Nov 6.
- Background: PubMed 31595799Abdul Salim S, Tran H, Thongprayoon C, Fulop T, Cheungpasitporn W. Comparison of drug-coated balloon angioplasty versus conventional angioplasty for arteriovenous fistula stenosis: Systematic review and meta-analysis. J Vasc Access. 2020 May;21(3):357-365. doi: 10.1177/1129729819878612. Epub 2019 Oct 9.
- Background: PubMed 21285890Kelsch B, Scheller B, Biedermann M, Clever YP, Schaffner S, Mahnkopf D, Speck U, Cremers B. Dose response to Paclitaxel-coated balloon catheters in the porcine coronary overstretch and stent implantation model. Invest Radiol. 2011 Apr;46(4):255-63. doi: 10.1097/RLI.0b013e31820577df.
- Background: PubMed 30561254Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Karnabatidis D. Risk of Death Following Application of Paclitaxel-Coated Balloons and Stents in the Femoropopliteal Artery of the Leg: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Am Heart Assoc. 2018 Dec 18;7(24):e011245. doi: 10.1161/JAHA.118.011245.
- Background: PubMed 31954604Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Paraskevopoulos I, Karnabatidis D. Risk of Death and Amputation with Use of Paclitaxel-Coated Balloons in the Infrapopliteal Arteries for Treatment of Critical Limb Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Vasc Interv Radiol. 2020 Feb;31(2):202-212. doi: 10.1016/j.jvir.2019.11.015. Epub 2020 Jan 15.
- Background: PubMed 32043432Cao Z, Li J, Zhang T, Zhao K, Zhao J, Yang Y, Jiang C, Zhu R, Li Z, Wu W. Comparative Effectiveness of Drug-Coated Balloon vs Balloon Angioplasty for the Treatment of Arteriovenous Fistula Stenosis: A Meta-analysis. J Endovasc Ther. 2020 Apr;27(2):266-275. doi: 10.1177/1526602820902757. Epub 2020 Feb 11.
- Background: PubMed 31608741Tang TY, Choke EC, Walsh SR, Tiwari A, Chong TT. What Now for the Endovascular Community After the Paclitaxel Mortality Meta-Analysis: Can Sirolimus Replace Paclitaxel in the Peripheral Vasculature? J Endovasc Ther. 2020 Feb;27(1):153-156. doi: 10.1177/1526602819881156. Epub 2019 Oct 14. No abstract available.
- Background: PubMed 30898253Ali RM, Abdul Kader MASK, Wan Ahmad WA, Ong TK, Liew HB, Omar AF, Mahmood Zuhdi AS, Nuruddin AA, Schnorr B, Scheller B. Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv. 2019 Mar 25;12(6):558-566. doi: 10.1016/j.jcin.2018.11.040.
- Individual participant dataSharing planned: No
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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.
Tjun Yip Tang principal investigator
Singapore General Hospital
Tze Tec Chong principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arteriovenous Fistula and Dialysis Access Malfunction, run by Singapore General Hospital at 1 site in Singapore.
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 8 inclusion and 18 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 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Primary Patency (time frame: 6 months post-index procedure). 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 NCT04629118, which also lists 13 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 27 Sep 2021.