Clinical Study of POSS-PCU Vascular Grafts for Vascular Access

Renal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02301312
• Other study ID #: 14/0276
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2021
• Est. completion date: April 2025

Study information

• Verified date: October 2019
• Source: University College, London
• Contact: Nimrita Verma
• Phone: 020 7679 6159
• Email: n.verma[@]ucl.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Device:
• POSS-PCU vascular graft
New vascular access graft

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Patency rate	Patency rate of POSS-PCU Graft at 2weeks, 3, 6, and 12 months as measured with US Doppler.	12 months
Secondary	Secondary patency rate	Any surgical or endovascular intervention required to maintain the patency of the grafts up to the 18 month time point.	18 months