An observational study in Arterio-venous Fistula, Dialysis Access Malfunction and Hemodialysis Access Failure, sponsored by Singapore General Hospital. Status unknown at 1 site in Singapore. Open to participants aged 21 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-05-11.
Sponsored by Singapore General Hospital · Observational
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 is associate 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 showed that DCB appears to be a better and safe alternative to conventional balloon angioplasty (CBA) in treating patients with HD stenosis based on 6- and 12-months primary patency and increased intervention free period.
The Passeo-18 Lux (Biotronik Asia Pacific Pte Ltd (Singapore)) drug-coated balloon (DCB) is packaged with a low dose of paclitaxel. Recent studies have shown that low dose coating of paclitaxel with this DCB is useful for preventing restenosis, decrease lumen loss and target lesion revascularization in the peripheral vasculature6 but has not been tested in the dialysis access circuit.
267 studies on the registry are indexed under Arteriovenous Fistula; 44 are open to participants now.
This study's planned enrollment of 100 is close to 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.
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Patients who have a native upper limb AVF or AVG, that is currently in use for haemodialysis, which has a significant inflow or outflow stenosis. Significant stenosis defined as diameter greater than 50% compared to adjacent normal segment and/or other evidence of AVF malfunction. Malfunction defined as the AVF performing inadequate dialysis and clinical signs of a failing dialysis access. Inadequate fistula volume flow - Qa as measured by ultrasound \< 500mL/min as probably inadequate. Dialysis numbers: - Qb - a significant stenosis is suggested when the pump speed is \< 200ml/min, venous pressure is > 140 mmHg and/or arterial pressure > - 100mmHg. Maximum of 2 discrete stenoses (separated by > 3cm) are allowed to be included.
Stenosis had to be initially treated successfully with a high-pressure plain balloon prior to PCB treatment as defined by:
Exclusion Criteria:
Patients with failing dialysis access, treated lesions located between the anastomosis to the axillary-subclavian vein junction.
Device: Passeo-18 Lux
Patients with significant inflow or outflow stenosis between the anastomosis to the axillary-subclavian vein junction, as defined by the insertion of the cephalic vein, who had undergone fistuloplasty with Passeo-18 Lux
Also known as: Biotronik
6-month Target Lesion Primary Patency
Patency with no re-intervention to the area 5mm proximal to, within, and 5mm distal to, the index treatment segment. TLPP ends when any of the following occur: 1) clinically driven re-intervention to the treatment 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/AVG due to an inability to treat the treatment segment
Time frame: 6-month post-procedure
Primary Patency
A duration of time measuring intra-access patency that starts from the date of angioplasty with Passeo-18 Lux DCB to the date of one of the following events: thrombosis, or any intervention to facilitate, maintain or re-establish patency (e.g. angioplasty)
Time frame: 12 months post-op
Primary assisted patency
Interval date of angioplasty with Passeo-18 Lux DCB until thrombosis
Time frame: 12 months post-op
Secondary Patency
A duration of time measuring intra-access patency that starts from the date of angioplasty with Passeo-18 Lux DCB to the date of vascular access abandonment
Time frame: 12 months post-op
Number of reinterventions
Time frame: 12 months post-op
Adverse Events
Intraoperative/perioperative complications, infections, revision surgeries required
Time frame: 12 months post-op
Plan to share: No
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Singapore General Hospital