Clinical Study of POSS-PCU Vascular Grafts for Vascular Access
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02301312|
Recruitment Status : Not yet recruiting
First Posted : November 25, 2014
Last Update Posted : November 1, 2018
|Condition or disease||Intervention/treatment||Phase|
|Renal Insufficiency||Device: POSS-PCU vascular graft||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Investigation to Assess the Safety and Performance of POSS-PCU Small Diameter Grafts as Conduits in Arteriovenous (AV) Access|
|Estimated Study Start Date :||April 2019|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2023|
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
- 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 ]
- Patency rate [ Time Frame: 12 months ]Patency rate of POSS-PCU Graft at 2weeks, 3, 6, and 12 months as measured with US Doppler.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301312
|Contact: Nimrita Verma||020 7679 email@example.com|
|Contact: Janice Tsui, MD FRCS||+44 2077940500 ext firstname.lastname@example.org|