Hemodialysis Arteriovenous Fistula Stenoses
Conditions
Interventions
1:Balloon angioplasty with conventional balloon catheter
2:Balloon angioplasty with AngioSculpt PTA balloon catheter
Sponsors
Princess Margaret Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Percutaneous Transluminal Angioplasty will performed in end-stage renal failure patients with hemodynamically significant (defined as >50%) stenosis of the autogenous fistula.
Exclusion criteria
Exclusion criteria: - Patient refusing treatment - The reference segment diameter is not suitable for available catheter design - Previous PTA for the same lesion - Associated significant (>50%) central venous stenosis - Multiple significant (>50%) stenosis - The patient is minor (<18 years old) - Previous access thrombectomy - Positive pregnancy test result within 7 days before enrolment - Patient is scheduled for a kidney transplant - Life expectancy <6 months - The patient has a known allergy to heparin, aspirin or other anticoagulant/ antiplatelet therapies - The patient is currently enrolled in another investigational device or drug trial - The patient is currently breast-feeding, pregnant or intends to become pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patency of the target lesion of control and experimental groups; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate angiographic scoring success, defined as residual diameter stenosis smaller than 30% and absence of flow-limiting dissection on visual assessment after scoring balloon treatment;Hemodialysis success, defined as restoration of normal blood flow through the treated vascular lesion;Peri-procedural complications (less than 24 hours) will be evaluated including death, stroke, myocardial infarction of the scoring balloon treated lesion, significant distal embolization in the target limb and thrombosis of target limb.;Complications at 30 days including death, stroke, myocardial infarction, emergent percutaneous or surgical revascularization of the scoring balloon treated lesion, significant distal embolization in the target limb and thrombosis of target limb.; | — |
Countries
China
Contacts
Public ContactWing-hang Luk
Diagnostic Radiology Department, Princess Margaret Hospital
Outcome results
None listed