ACTRN12616000789460
Completed
Phase 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 enrollmentJune 16, 2016
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Dysfunctional haemodialysis access
- Sponsor
- Department of Surgery, Pamela Youde Nethersole Eastern Hospital, Hong Kong
- Enrollment
- 40
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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