Trial reportTrials2016
Paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis (PAVE): study protocol for a randomised controlled trial.
Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it, 29 citations in OpenAlex.
- Drug-coated balloon angioplasty for failing haemodialysis access: meta-analysis of randomized clinical trials.The British journal of surgery · 2021Pooled it
- Circulating Interleukin-6 and CD16 positive monocytes increase following angioplasty of an arteriovenous fistula.Scientific reports · 2022Trial
- Paclitaxel coated-balloon (PCB) versus standard plain old balloon (POB) fistuloplasty for failing dialysis access.Annals of the Royal College of Surgeons of England · 2020Trial
- Trial
- Procedure and Clinical Success of Drug-Coated Balloon Fistuloplasty of the Drainage Vein in Dysfunctional Native Arteriovenous Fistulas.Journal of interventional cardiology · 2021Article
- Factors associated with outcome after successful radiological intervention in arteriovenous fistulas: A retrospective cohort.The journal of vascular access · 2019Article
- Disruptive technological advances in vascular access for dialysis: an overview.Pediatric nephrology (Berlin, Germany) · 2018Review
- Arteriovenous Access Failure, Stenosis, and Thrombosis.Canadian journal of kidney health and disease · 2016Article
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
14 authors at 7 institutions in 1 country.
Funding
Abstract
backgroundThe initial therapy for a stenosis in an arteriovenous fistula used for haemodialysis is radiological balloon dilatation or angioplasty. The benefit of angioplasty is often short-lived, intervention-free survival is reported to be 40-50 % at 1 year. Previous small studies and observational data suggest that paclitaxel-coated balloons may be of benefit in improving outcomes after fistuloplasty of stenotic arteriovenous fistulae. METHODS/
designWe have designed a multicentre, double-blind randomised controlled trial to test the superiority of paclitaxel-coated balloons for preventing restenosis after fistuloplasty in patients with a native arteriovenous fistula. Two hundred and eleven patients will be followed up for a minimum of 1 year. Inclusion criteria include a clinical indication for a fistuloplasty, an access circuit that is free of synthetic graft material or stents, and a residual stenosis of 30 % or less after plain balloon fistuloplasty. Exclusion criteria include a synchronous venous lesion in the same access circuit, location of the stenosis central to the thoracic inlet or a thrombosed access circuit at the time of treatment. The primary endpoint is time to end of target lesion primary patency. This is defined as a clinically-driven radiological or surgical re-intervention at the treatment segment, thrombosis that includes the treatment segment, or abandonment of the access circuit due to an inability to re-treat the treatment segment. Secondary endpoints include angiographic late lumen loss, time to end of access circuit cumulative patency, the total number of interventions, and quality of life. The trial is funded by the National Institute for Health Research. DISCUSSION: We anticipate that this trial will provide rigorous data that will determine the efficacy of additional paclitaxel-coated balloon fistuloplasty versus plain balloon fistuloplasty only to preserve the patency of arteriovenous fistulae used for haemodialysis.
trial registrationISRCTN14284759 . Registered on 28 October 2015.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.