Endovascular salvage of failing arterio-venous fistulas utilising sirolimus eluting balloons: Six months results from the ISABELLA trial.
Sirolimus coated balloon
arterio-venous fistula
outcome
safety
target lesion primary patency
Journal
The journal of vascular access
ISSN: 1724-6032
Titre abrégé: J Vasc Access
Pays: United States
ID NLM: 100940729
Informations de publication
Date de publication:
Sep 2023
Sep 2023
Historique:
medline:
8
11
2023
pubmed:
31
12
2021
entrez:
30
12
2021
Statut:
ppublish
Résumé
Aim of this pilot clinical study was to evaluate the safety and efficacy of the Prospective single-centre, multi-investigator, non-consecutive, non-blinded single arm trial. Forty end-stage renal failure Asian patients with a dysfunctional AVF underwent SEB angioplasty between May and November 2020. All stenotic lesions were prepared with high pressure non-compliant balloon angioplasty prior to SEB angioplasty. Endpoints of interest included target lesion primary patency and circuit access patency and safety through 30 days. All patients received dual antiplatelet therapy for 1 month and were followed up with Duplex ultrasound at 6 months. There was one subject dropout so final Fistuloplasty using the novel
Sections du résumé
BACKGROUND
UNASSIGNED
Aim of this pilot clinical study was to evaluate the safety and efficacy of the
METHODS
UNASSIGNED
Prospective single-centre, multi-investigator, non-consecutive, non-blinded single arm trial. Forty end-stage renal failure Asian patients with a dysfunctional AVF underwent SEB angioplasty between May and November 2020. All stenotic lesions were prepared with high pressure non-compliant balloon angioplasty prior to SEB angioplasty. Endpoints of interest included target lesion primary patency and circuit access patency and safety through 30 days. All patients received dual antiplatelet therapy for 1 month and were followed up with Duplex ultrasound at 6 months.
RESULTS
UNASSIGNED
There was one subject dropout so final
CONCLUSIONS
UNASSIGNED
Fistuloplasty using the novel
Identifiants
pubmed: 34965764
doi: 10.1177/11297298211067059
doi:
Substances chimiques
Coated Materials, Biocompatible
0
Sirolimus
W36ZG6FT64
Types de publication
Clinical Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1008-1017Déclaration de conflit d'intérêts
Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: TYT and TTC have received physician-initiated study grants and honoraria for speaking engagements from M.A. MedAlliance SA.