Renal InsufficiencyNCT02301312
Clinical Study of POSS-PCU Vascular Grafts for Vascular Access
A study testing POSS-PCU vascular graft in people with Renal Insufficiency, run by University College, London.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- POSS-PCU vascular graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- AND 1 of the following:
- Oral contraceptive or hormonal therapy (e.g. hormone implants).
- Placement of an intra-uterine device.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Renal Insufficiency
- Being tested
- POSS-PCU vascular graft
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POSS-PCU vascular graftDevice
New vascular access graft
| Study group | Role | What they receive |
|---|---|---|
| POSS-PCU graft | Experimental | POSS-PCU vascular graft will be used to create vascular access for dialysis. Receives: Device: POSS-PCU vascular graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 30 days
Secondary outcomes (2)
Patency rate
Patency rate of POSS-PCU Graft at 2weeks, 3, 6, and 12 months as measured with US Doppler.
Measured: 12 months
Secondary patency rate
Any surgical or endovascular intervention required to maintain the patency of the grafts up to the 18 month time point.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2014 (estimated)
- Study startApr 2021 (estimated)
- Primary completionApr 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301312
- Sponsor's protocol ID
- 14/0276
- Status last verified
- Oct 2019
- First submitted
- 21 Nov 2014
- Last updated
- 20 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28347955
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Investigation to Assess the Safety and Performance of POSS-PCU Small Diameter Grafts as Conduits in Arteriovenous (AV) Access
- ClinicalTrials.gov ID
- NCT02301312
- Acronym / sponsor ID
- 14/0276
- Conditions
- Renal Insufficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 25 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POSS-PCU graft | Experimental | Device: POSS-PCU vascular graftPOSS-PCU vascular graft will be used to create vascular access for dialysis. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POSS-PCU vascular graftNew vascular access graft | Device | POSS-PCU graft |
Primary outcome
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
2 secondary outcomes
Patency rate
Time frame: 12 months
Secondary patency rate
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Derived from this study: PubMed 28347955Askari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing POSS-PCU vascular graft in people with Renal Insufficiency, run by University College, London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nimrita Verma (020 7679 6159, n.verma@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patency rate (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02301312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.