ACTRN12616000789460CompletedPhase 4
Paclitaxel-eluting balloon Versus plain angioplasty balloon for dysfunctional dialysis access: a prospective double-blinded randomized controlled trial
Department of Surgery, Pamela Youde Nethersole Eastern Hospital, Hong Kong0 sites40 target enrollmentStarted: June 16, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 40
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (—)
- Sex
- All
Inclusion Criteria
- •Native arteriovenous fistula or prosthetic arteriovenous graft in the upper limb
- •Vascular access actively used for hemodialysis
- •At least 1 previous successful session of hemodialysis via access
- •Clinical signs of failing access due to presence of significant anatomic stenosis
- •Detection of elevated venous pressure during dialysis and/or decreased blood flow
- •Angiographically/sonographically proven venous outflow stenosis >50%
Exclusion Criteria
- •Patient unable to provide informed consent
- •Patient unable to abide with study follow-up protocol
- •Patient participating in other relevant or conflicting studies
- •Vascular access circuit placed in the lower extremities
- •Bare metal stent or stent graft placed previously
- •Hemodynamically significant stenosis of the central venous system
- •Metastatic malignancy or other terminal medical condition
- •Limited life expectancy (<6 months)
- •Blood coagulation disorders
- •Sepsis or active infection
- •Recent arm thrombophlebitis (<6 months)
- •Allergy or other known contraindication to iodinated contrast media, heparin, or paclitaxel
Investigators
Similar Trials
Completed
Not Applicable
Paclitaxel-Coated versus Plain Balloon Angioplasty for Dysfunctional Autogenous Radiocephalic Arteriovenous FistulasDiseases of the circulatory systemKCT0004870Gachon University Gil Medical Center40
Active, not recruiting
Not Applicable
Drug-Eluting Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis (DEBAVAS)Dysfunction of Hemodialysis Vascular Access (Fistula and Graft)NCT02408822Centre Hospitalier Universitaire de Nice52
Unknown
Not Applicable
Drug-coated Balloon Versus Drug-eluting Stent in Acute Myocardial InfarctionAcute Myocardial InfarctionCoronary Artery DiseaseNCT02219802Onze Lieve Vrouwe Gasthuis120
Terminated
Phase 4
A COMparison Between PAClitaxel-coated Balloon and pacliTaxel-eluting Stent in the Treatment of In-Stent Restenosis (COMPACT-ISR)Unstable AnginaStable AnginaNCT01204320Ospedale San Donato154
Recruiting
Phase 3
Revascularization with paclitaxel-coated balloon angioplasty versus drug-eluting stenting in acute myocardial infarction - a randomized controlled trialacute myocardial infarction10011082NL-OMON41152Onze Lieve Vrouwe Gasthuis120