Clinical Study of POSS-PCU Vascular Grafts for Vascular Access

April 17, 2020 updated by: University College, London

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
18 months
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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patency rate
Time Frame: 12 months
Patency rate of POSS-PCU Graft at 2weeks, 3, 6, and 12 months as measured with US Doppler.
12 months
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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

April 1, 2025

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

November 21, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (Estimate)

November 25, 2014

Study Record Updates

Last Update Posted (Actual)

April 20, 2020

Last Update Submitted That Met QC Criteria

April 17, 2020

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/0276

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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