A study to evaluate the safety and effectiveness of the NICAST Polyurethane vascular access graft

• Register: SLCTR
• Last refreshed on: 27 April 2013
• Main ID: SLCTR/2008/009
• Date of registration: 16/05/2008
• Primary sponsor: Nicast Ltd
• Public title: A study to evaluate the safety and effectiveness of the NICAST Polyurethane vascular access graft
• Scientific title: A prospective open label randomized clinical study to evaluate the safety and effectiveness of the NICAST polyurethane vascular access graft
• Date of first enrolment: 7/7/2007
• Target sample size: 30
• Recruitment status: Recruiting
• URL: http://www.slctr.lk/trial_details.asp?reg_id={7F94A3E1-1BDC-4B3B-B41A-8091AB5C6331}
• Study type: Interventional
• Study design: Prospective open label randomized clinical study

Countries of recruitment

Sri Lanka

Contacts

• Name: Mandika Wijeyaratne
• Affiliation: Head of the Department, Department of Surgery, Faculty of Medicine, Colombo

• Name: Mandika Wijeyaratne
• Affiliation: Head of the Department, Department of Surgery, Faculty of Medicine, Colombo

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Using NICAST polyurethane graft for vascular access for haemodialysis in chronic renal failure patients.

Intervention(s)

Use NICAST graft as a arteriovenous conduit for vascular access in haemodialysis in chronic renal failure patients

Primary Outcome(s)

•Primary patency
•Incidence of thrombosis
•18 month functional patency rates
•Overall incidence of intraoperative and postoperative complications

Secondary Outcome(s)

-Time to first puncture of the graft
-Frequency of temporary catheter use prior to first puncture
-Difficulty of graft puncture
-Haemostasis time

Secondary ID(s)

None

Source(s) of Monetary Support

NICAST Ltd. Global Park, 2 Yodfat Street, Nothern Industrial Zone, Lod 71291, Israel