FLEX®-DCB Dialysis ACCESS Stenosis Study (AVAFLEX)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03566927|
Recruitment Status : Active, not recruiting
First Posted : June 25, 2018
Last Update Posted : August 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Arteriovenous Fistula||Combination Product: FLEX Scoring Catheter with Lutonix DCB||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||FLEX®-DCB Dialysis ACCESS Stenosis Study|
|Actual Study Start Date :||May 29, 2018|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2021|
Experimental: FLEX Scoring Catheter plus DCB
This is a single-arm study. All patients will be treated with the FLEX Scoring Catheter, then a standard balloon angioplasty, followed by a Lutonix® drug-coated balloon (DCB).
Combination Product: FLEX Scoring Catheter with Lutonix DCB
Treatment by the FLEX Scoring Catheter, a plain balloon angioplasty, followed by a Lutonix DCB.
- Target Lesion Primary Patency [ Time Frame: 9 Months ]Target Lesion Primary Patency at 9 months defined as the time interval of uninterrupted patency from initial study treatment to the next access thrombosis or intervention performed on the target lesion.
- Index of Patency Function [ Time Frame: 3, 6, 9 Months ]Index of Patency Function defined as the average time between interventions.
- Assess Secondary Patency [ Time Frame: 3, 6, 9 Months ]Assess Secondary Patency defined as the time interval from initial study treatment to abandonment of the vascular access circuit.
- Number of Interventions [ Time Frame: 9 Months ]Mean cumulative interventions per subjects over study duration.
- Percentage of Patients with Freedom from Adverse Events [ Time Frame: 1 Month ]Freedom from major device, procedure and treatment site-related adverse events through 30 days' post procedure.
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): NCT03566927
|United States, South Carolina|
|Dialysis Access Institute|
|Orangeburg, South Carolina, United States, 29118|