Using NICAST polyurethane graft for vascular access for haemodialysis in chronic renal failure patients.
Conditions
Interventions
Use NICAST graft as a arteriovenous conduit for vascular access in haemodialysis in chronic renal failure patients
Sponsors
Nicast Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Candidates for implantattion of a prosthetic vascular access graft for haemodialysis access.these are patients who are not eligible for creation of native fistulae according to the standard of care in the medical center 2. Male or female subjects 18 year or older of any race 3. Subjects willing to participate as evidenced by signing the written informed consent
Exclusion criteria
Exclusion criteria: Subjects with any medical condition that would expose the subject to increased risk by the investigational device or procedure according to the investigator's decision Subjects with elevated WBC counts Subjects with bilirubin level >3mg/dl Concurrent existence of another vascular access graft in the same limb Subjects with known hypersensitivity or allergy to polyurethane products or any other contraindication to implantation of a polyurethane graft Female subjects who are pregnant or lactating Subjects participating in any other clinical study at the same time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| •Primary patency •Incidence of thrombosis •18 month functional patency rates •Overall incidence of intraoperative and postoperative complications [] | — |
Secondary
| Measure | Time frame |
|---|---|
| -Time to first puncture of the graft -Frequency of temporary catheter use prior to first puncture -Difficulty of graft puncture -Haemostasis time [] | — |
Countries
Sri Lanka
Contacts
Public ContactMandika Wijeyaratne
Head, Department of Surgery,
Outcome results
None listed