Clinical Trial: Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Prospective, Global, Multicenter, Randomized, Controlled Study Comparing Lutonix® 035 AV Drug Coated Balloon PTA Catheter vs. Standard Balloon PTA Catheter for the Treatment of Dysfunctional
Brief Summary: This prospective, global, multicenter, randomized, controlled study is designed to evaluate the safety and effectiveness of the Lutonix 035 AV Drug Coated Balloon PTA Catheter compared to a standard PTA Catheter in treating subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.
Detailed Summary:
Sponsor: C. R. Bard
Current Primary Outcome:
- Efficacy: Primary Patency [ Time Frame: 6 months ]Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis.
- Safety: Freedom from any serious adverse event(s) involving the AV access circuit. [ Time Frame: 30 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Target Lesion Primary Patency [ Time Frame: 12 months ]
- Number of interventions, required to maintain target lesion patency [ Time Frame: 12 months ]
- Access Circuit Primary Patency [ Time Frame: 6 months ]
- Access Circuit Primary Patency [ Time Frame: 12 months ]
- Target Lesion Primary Patency [ Time Frame: 3, 9, 18 and 24 months ]
- Access Circuit Primary Patency [ Time Frame: 3, 9, 18 and 24 months ]
- Device, Procedural and Clinical Success [ Time Frame: 24 months ]
- Device Success: Successful delivery to the target lesion, deployment, and retrieval at index procedure.
- Procedural Success: At least one indicator of hemodynamic success (e.g., physical examination with restoration of a thrill, direct measurement of flow) in the absence of peri-procedural (index procedure and through hospital stay) Serious Adverse Device Effects (SADEs).
- Clinical Success: The resumption of dialysis for at least one session after the index procedure.
- Target Lesion Primary Patency [ Time Frame: 6 months ]Target Lesion Primary Patency evaluated for subjects in whom a fiber pre-dilation balloon was used before the Lutonix AV DCB as compared to those in whom a non-fiber pre-dilation balloon.
- Abandonment of permanent access in the index extremity [ Time Frame: 3, 6, 9, 12, 18 and 24 months ]The index access site is abandoned and a new access site is created.
- Number of interventions, required to maintain access circuit patency [ Time Frame: 3, 6, 9, 12, 18 and 24 months ]
- Number of interventions, required to maintain target lesion patency [ Time Frame: 3, 6, 9, 18 and 24 months ]
- Rate of device and procedure related adverse events [ Time Frame: 1, 3, 6, 9, 12, 18 and 24 months ]
Original Secondary Outcome:
- Target Lesion Primary Patency [ Time Frame: 12 months ]
- Number of interventions, required to maintain target lesion patency [ Time Frame: 12 months ]
- Access Circuit Primary Patency [ Time Frame: 6 months ]
- Access Circuit Primary Patency [ Time Frame: 12 months ]
- Target Lesion Primary Patency [ Time Frame: 3, 9, 18 and 24 months ]
- Access Circuit Primary Patency [ Time Frame: 3, 9, 18 and 24 months ]
- Device, Procedural and Clinical Success [ Time Frame: 24 months ]
- Device Success: Successful delivery to the target lesion, deployment, and retrieval at index procedure.
- Procedural Success: At least one indicator of hemodynamic success (e.g., physical examination with restoration of a thrill, direct measurement of flow) in the absence of peri-procedural (index procedure and through hospital stay) Serious Adverse Device Effects (SADEs).
- Clinical Success: The resumption of dialysis for at least one session after the index procedure.
- Abandonment of permanent access in the index extremity [ Time Frame: 3, 6, 9, 12, 18 and 24 months ]The index access site is abandoned and a new access site is created.
- Number of interventions, required to maintain access circuit patency [ Time Frame: 3, 6, 9, 12, 18 and 24 months ]
- Number of interventions, required to maintain target lesion patency [ Time Frame: 3, 6, 9, 18 and 24 months ]
- Rate of device and procedure related adverse events [ Time Frame: 1, 3, 6, 9, 12, 18 and 24 months ]
Information By: C. R. Bard
Dates:
Date Received: May 7, 2015
Date Started: June 2015
Date Completion: September 2018
Last Updated: May 18, 2017
Last Verified: May 2017