Status:
UNKNOWN
Clinical Study of POSS-PCU Vascular Grafts for Vascular Access
Lead Sponsor:
University College, London
Conditions:
Renal Insufficiency
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study evaluates the safety and performance of a new vascular graft made of POSS-PCU as a vascular access conduit for haemodialysis. 30 patients requiring access for dialysis will be enrolled and ...
Eligibility Criteria
Inclusion
- Subjects requiring vascular access for haemodialysis
- Subjects with no suitable vein.
- Subjects aged 18 - 80 years old
- Subjects are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained
- Patients of child bearing potential, who are sexually active, must agree to the use of 2 highly effective forms of contraception throughout their participation in the study and for 6 months after completion of treatment:
- Condom with spermicide.
- AND 1 of the following:
- Oral contraceptive or hormonal therapy (e.g. hormone implants).
- Placement of an intra-uterine device.
Exclusion
- Subjects with predicted short-term survival (less than 18 months) or poor prognosis (this will be on the discretion of the clinician in charge)
- Subjects with left ventricle ejection fraction (LVEF) \<20% diagnosed on ECHO either pre-procedure or documented within the previous 3 months prior to consent.
- Pregnant or lactating
- Allergies to any constituents of the graft material
- Patients who are infected or colonized with Methicillin Resistant Staphylococcus Aureus (MRSA).
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02301312
Start Date
April 1 2021
End Date
April 1 2025
Last Update
April 20 2020
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