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 AV Fistulae

C. R. Bard23 sites in 1 country285 target enrollmentJune 2015

ConditionsArteriovenous Fistula

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Arteriovenous Fistula
Sponsor: C. R. Bard
Enrollment: 285
Locations: 23
Primary Endpoint: Percentage of Participants With Target Lesion Primary Patency (TLPP) at 6 Months Post Index Procedure
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2015

End Date

June 2018

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

C. R. Bard

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥21 years;
•The subject is legally competent, has been informed of the nature, the scope and the relevance of the study, voluntarily agrees to participation and the study's provisions, and has duly signed the informed consent form (ICF);
•Arteriovenous fistula located in the arm;
•Native AV fistula was created ≥30 days prior to the index procedure and has undergone one or more hemodialysis sessions;
•Venous stenosis of an AV fistula with the target lesion located from the anastomosis to the axillosubclavian junction and an abnormality attributable to the stenosis as defined by K/DOQI guidelines.;
•Successful pre-dilation of the target lesion with a percutaneous transluminal angioplasty (PTA) balloon;
•Intended target lesion.

Exclusion Criteria

•Women who are pregnant, lactating, or planning on becoming pregnant during the study;
•Hemodialysis access is located in the leg;
•Subject has more than two lesions in the access circuit;
•Subject has a secondary non-target lesion that cannot be successfully treated;
•Target lesion is located central to the axillosubclavian junction;
•The subject has a secondary lesion located in the central venous system (central to the axillosubclavian junction);
•A thrombosed access;
•Surgical revision of the access site planned;
•Recent prior surgical interventions of the access site;
•Other planned treatment during the index procedure;

Outcomes

Primary Outcomes

Percentage of Participants With Target Lesion Primary Patency (TLPP) at 6 Months Post Index Procedure

Time Frame: 6 months post index procedure

Primary Patency is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis. Target Lesion Primary Patency (TLPP) ends with a clinically driven re-intervention of the target lesion or access thrombosis.

Number of Participants With Freedom From Any Serious Adverse Event(s) Involving the AV Access Circuit at 30 Days Post Index Procedure.

Time Frame: 30 Days Post Index Procedure

The primary safety endpoint is freedom from localized or systemic serious adverse events through 30 days that reasonably suggests the involvement of the AV access circuit (CEC adjudicated).

Secondary Outcomes

Number of Interventions Required to Maintain Access Circuit Primary Patency (ACPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure(3, 6, 9, 12, 18 and 24 Months Post Index Procedure)
Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated)(1, 3, 6, 9, 12, 18 and 24 Months Post Index Procedure)
Number of Participants With Target Lesion Primary Patency (TLPP) by Fiber Pre-Dilation Balloon at 6 Months Post Index Procedure(6 Months Post Index Procedure)
Percentage of Participants With Device, Procedural and Clinical Success(Device and Procedural Success: At time of Index Procedure; Clinical Success: at 1st session of dialysis following index procedure)
Number of Procedure Related Serious Adverse Events (CEC Adjudicated) at 1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure(1, 3, 6, 9, 12, 18, and 24 Months Post Index Procedure)
Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months(3, 9, 12, 18, and 24 Months Post Index Procedure)
Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure(3, 6, 9, 12, 18 and 24 Months Post Index Procedure)
Number of Interventions Required to Maintain Target Lesion Primary Patency (TLPP) at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure(3, 6, 9, 12, 18, and 24 Months Post Index Procedure)