A study to evaluate the safety and effectiveness of the NICAST Polyurethane vascular access graft
- Conditions
- sing NICAST polyurethane graft for vascular access for haemodialysis in chronic renal failure patients.
- Registration Number
- SLCTR/2008/009
- Lead Sponsor
- icast Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 30
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method •Primary patency •Incidence of thrombosis •18 month functional patency rates •Overall incidence of intraoperative and postoperative complications []<br>
- Secondary Outcome Measures
Name Time Method -Time to first puncture of the graft -Frequency of temporary catheter use prior to first puncture -Difficulty of graft puncture -Haemostasis time []<br>