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Clinical Study of POSS-PCU Vascular Grafts for Vascular Access

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02301312
Recruitment Status : Not yet recruiting
First Posted : November 25, 2014
Last Update Posted : April 20, 2020
Information provided by (Responsible Party):
University College, London

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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency Device: POSS-PCU vascular graft Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Investigation to Assess the Safety and Performance of POSS-PCU Small Diameter Grafts as Conduits in Arteriovenous (AV) Access
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2025

Arm Intervention/treatment
Experimental: POSS-PCU graft
POSS-PCU vascular graft will be used to create vascular access for dialysis.
Device: POSS-PCU vascular graft
New vascular access graft

Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. Patency rate [ Time Frame: 12 months ]
    Patency rate of POSS-PCU Graft at 2weeks, 3, 6, and 12 months as measured with US Doppler.

  2. Secondary patency rate [ Time Frame: 18 months ]
    Any surgical or endovascular intervention required to maintain the patency of the grafts up to the 18 month time point.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02301312

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Contact: Nimrita Verma 020 7679 6159
Contact: Janice Tsui, MD FRCS +44 2077940500 ext 33938

Sponsors and Collaborators
University College, London
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University College, London Identifier: NCT02301312    
Other Study ID Numbers: 14/0276
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases