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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| POSS-PCU graft | Experimental | POSS-PCU vascular graft will be used to create vascular access for dialysis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| POSS-PCU vascular graft | Device | New vascular access graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patency rate | Patency rate of POSS-PCU Graft at 2weeks, 3, 6, and 12 months as measured with US Doppler. | 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. |
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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:
AND 1 of the following:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nimrita Verma | Contact | 020 7679 6159 | n.verma@ucl.ac.uk | |
| Janice Tsui, MD FRCS | Contact | +44 2077940500 | 33938 | janice.tsui@ucl.ac.uk |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28347955 | Derived | 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. |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 18 months |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |