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Clinical Trials/NCT02301312
NCT02301312Not yet recruitingNot Applicable

A Clinical Investigation to Assess the Safety and Performance of POSS-PCU Small Diameter Grafts as Conduits in Arteriovenous (AV) Access

University College, London0 sites30 target enrollmentStarted: April 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
30
Primary Endpoint
Patency rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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 monitored at regular intervals for 18 months.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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 Criteria

  • •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).

Outcomes

Primary Outcomes

Patency rate

Time Frame: 18 months

The primary performance end point of the study is the patency rate of the POSS-PCU graft at the end of the 18 months as measured with US Doppler, which will be compared to the known patency rate for the PTFE graft

Safety endpoint of this study is defined as any Serious Adverse Event related to the implantation procedure or device implantation within 30 days of implantation procedure

Time Frame: 30 days

Secondary Outcomes

  • Patency rate(12 months)
  • Secondary patency rate(18 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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