An observational study in Dialysis Access Malfunction and Stenosis, sponsored by Singapore General Hospital. Status unknown at 1 site in Singapore. Open to participants aged 21 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-04-19.
Sponsored by Singapore General Hospital · Observational
Drug-coated balloon (DCB) angioplasty has been shown to be superior to POBA in the treatment of stenosis in AVF. This is because the very intervention used to treat underlying stenosis by POBA can induce vascular injury and accelerate intimal hyperplasia, resulting in rapid restenosis and need for repeated procedure to maintain vessel patency. The anti-proliferative drug that is coated on the surface of balloon is released to the vessel wall during balloon angioplasty and blunt the acceleration of intimal hyperplasia response, resulting in improved primary patency after angioplasty. Additionally, unlike stents, DCB does not leave a permanent structure that may impede future surgical revision. Recent randomized control trials (RCT) have shown the superiority of paclitaxel durg-coated balloon (PDCB) over POBA in the treatment of stenosis in AVFs. In a large multicenter RCT, PDCB was demonstrated to result in a 6-month target lesion primary patency of 82.2% compared to 59.5% for POBA. However, concerns had also arisen recently in the use of PDCB. In large lower limb studies involving the use of paclitaxel devices, meta-analysis by Katsanos et al had revealed increased late risk mortality in patient that are treated with PDCB or paclitaxel-coated stent.
Sirolimus drug-coated balloon (SDCB) is the new generation of drug eluting balloons that are available in the market. Compared to paclitaxel, sirolimus is cytostatic in its mode of action with a high margin of safety. It has a high transfer rate to the vessel wall and effectively inhibit neointimal hyperplasia in the porcine coronary model. The effectiveness of SDCB in patients with dialysis access dysfunction has been shown in a small pilot study in AVF stenosis and AVG thrombosis. SAVE AVF registry ams to assess the efficacy and safety of SDCB vs PDCB angioplasty.
267 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 80 observational studies indexed under Arteriovenous Fistula.
Browse Arteriovenous Fistula studies →Singapore General Hospital is the lead sponsor of 266 studies on the registry; 57 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with dysfunctional AVFs who have undergone balloon angioplasty or thrombolysis with PDCB or SDCB.
Exclusion Criteria:
Dysfunctional matured AVF that have underwent thrombolysis or balloon angioplasty with SDCB within 6 months witll be considered for the registry.
Device: Sirolimus Drug Coated Balloon
Dysfunctional matured AVF that have underwent thrombolysis or balloon angioplasty with PDCB within 6 months witll be considered for the registry.
Device: Paclitaxel Drug Coated Balloon
AVFs treated with SDCB
AVFs treated with PDCB
Circuit Primary Patency Rate at 6 months
Circuit primary patency is lost if patient has to undergo a repeat intervention that is clinically driven. Clinically driven indication may be based on physical examination such as loss of thrill, pulsatile flow or swollen arm.
Time frame: 6 months post-op
Circuit Primary Patency at 12 months
Circuit primary patency is lost if patient has to undergo a repeat intervention that is clinically driven. Clinically driven indication may be based on physical examination such as loss of thrill, pulsatile flow or swollen arm.
Time frame: 12 months post-op
Target Lesion Restenosis
Incidence of stenosis \>50% diameter of adjacent reference vessel segment from angiography images
Time frame: 6 and 12 months post-op
Number of repeat interventions to treated lesion
Time frame: 6 and 12 months post-op
Number of repeat interventions to maintain access circuit
This will include interventions to treated lesion
Time frame: 6 and 12 months post-op
Target lesion revascularization free interval
Interval from intervention to repeat clinically driven target lesion reintervention
Time frame: 12 months post-op
Complication rates of the procedure
Categorised according to SIR definitions (Aruny et al)
Time frame: Time of procedure
Mortality rates of patients
Time frame: 6 and 12 months post-op
Plan to share: No
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Singapore General Hospital