Clinical Study of POSS-PCU Vascular Grafts for Vascular Access

NCT02301312 | Unknown DMC

• 1 other identifier: 14/0276
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Renal Insufficiency

Outcome Measures

Primary Outcomes (2)

• Patency rate

  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

  30 days

Secondary Outcomes (2)

• Patency rate

  12 months

• Secondary patency rate

  18 months

Study Arms (1)

POSS-PCU graft

EXPERIMENTAL

POSS-PCU vascular graft will be used to create vascular access for dialysis.

Device: POSS-PCU vascular graft

Interventions

POSS-PCU vascular graft DEVICE

New vascular access graft

POSS-PCU graft

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University College, London: lead

Related Publications (1)

• Askari F, Shafieian M, Solouk A, Hashemi A. A comparison of the material properties of natural and synthetic vascular walls. J Mech Behav Biomed Mater. 2017 Jul;71:209-215. doi: 10.1016/j.jmbbm.2017.03.016. Epub 2017 Mar 23.

  PMID: 28347955 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Nimrita Verma

CONTACT

020 7679 6159; n.verma@ucl.ac.uk

Janice Tsui, MD FRCS

CONTACT

+44 2077940500; janice.tsui@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2014
• First Posted: November 25, 2014
• Study Start: April 1, 2021
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: April 20, 2020

Record last verified: 2019-10