FLEX Arteriovenous Access Registry
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|ClinicalTrials.gov Identifier: NCT04070365|
Recruitment Status : Recruiting
First Posted : August 27, 2019
Last Update Posted : October 14, 2019
|Condition or disease||Intervention/treatment|
|Peripheral Artery Disease Arteriovenous Fistula Stenosis Arteriovenous Graft Stenosis||Device: FLEX Vessel Prep System followed by angioplasty|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||FLEX Arteriovenous Access Registry|
|Actual Study Start Date :||October 9, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2021|
|FLEX Vessel Prep followed by angioplasty||
Device: FLEX Vessel Prep System followed by angioplasty
Eligible Arteriovenous Fistula (AVF)/Arteriovenous Graft (AVG) will be treated with the FLEX Vessel Prep system followed by angioplasty.
Other Name: Balloon Angioplasty
- Anatomic Success [ Time Frame: At the completion of the index procedure ]Defined as the angiographic percentage of stenosis post procedure as <30%
- Technical Success of the Device [ Time Frame: At the index procedure ]Delivery to the target lesion, deployment of the treatment element, and retrieval
- Clinical Success [ Time Frame: 6 Months ]The resumption of normal dialysis for at least one session.
- Procedural Success [ Time Frame: 6 Months ]Composite of anatomic and clinical success
- Target Lesion Primary Patency [ Time Frame: 6, 9 and 12 Months ]The time interval of uninterrupted patency from initial study treatment to the next thrombosis or intervention performed on the target lesion
- Circuit Primary Patency [ Time Frame: 6, 9, and Months ]The time interval from initial study treatment to the next access thrombosis or intervention performed within the vascular access circuit.
- Assisted Primary Patency [ Time Frame: 6, 9, and 12 Months ]The time interval from initial study treatment to occlusion (thrombosis) of the vascular access circuit.
- Access Secondary Patency [ Time Frame: 6, 9, and 12 Months ]The time interval from initial study treatment to abandonment of the vascular access circuit.
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): NCT04070365
|Contact: Katy Feeny||7632962027||KFeeny@venturemedgroup.com|
|United States, North Carolina|
|FirstHealth Moore Regional Hospital||Recruiting|
|Pinehurst, North Carolina, United States, 28374|
|United States, South Carolina|
|Dialysis Access Institute||Not yet recruiting|
|Orangeburg, South Carolina, United States, 29118|
|Principal Investigator:||John Aruny, MD||Dialysis Access Institute|