Study Comparing Lutonix AV Drug Coated Balloon vs Standard Balloon for Treatment of Dysfunctional AV Fistulae

Arteriovenous Fistula Clinical Trial

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 AV Fistulae

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02440022
• Other study ID #: CL0023-01
• Status: Completed
• Phase: Phase 3
• Start date: June 2015
• Est. completion date: June 2018

Study information

• Verified date: April 2020
• Source: C. R. Bard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: June 2018
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Age =21 years;

2. 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);

3. Arteriovenous fistula located in the arm;

4. Native AV fistula was created =30 days prior to the index procedure and has undergone one or more hemodialysis sessions;

5. 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.;

6. Successful pre-dilation of the target lesion with a percutaneous transluminal angioplasty (PTA) balloon;

7. Intended target lesion.

Exclusion Criteria:

1. Women who are pregnant, lactating, or planning on becoming pregnant during the study;

2. Hemodialysis access is located in the leg;

3. Subject has more than two lesions in the access circuit;

4. Subject has a secondary non-target lesion that cannot be successfully treated;

5. Target lesion is located central to the axillosubclavian junction;

6. The subject has a secondary lesion located in the central venous system (central to the axillosubclavian junction);

7. A thrombosed access;

8. Surgical revision of the access site planned;

9. Recent prior surgical interventions of the access site;

10. Other planned treatment during the index procedure;

11. Known contraindication (including allergic reaction) or sensitivity to iodinated contrast media, that cannot be adequately managed with pre-and post-procedure medication;

12. Known contraindication (including allergic reaction) or sensitivity to paclitaxel.

13. Subjects who are taking immunosuppressive therapy or are routinely taking

=10mg of prednisone per day;

14. Subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be noncompliant with the protocol or confound the data interpretation;

15. Subject has a life expectancy <12 months;

16. Anticipated for a kidney transplant;

17. Anticipated conversion to peritoneal dialysis;

18. Subject has a stent located in the target or secondary non target lesion;

19. Subject has an infected AV access or systemic infection;

20. Currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study.

Related Conditions & MeSH terms

• Arteriovenous Fistula
• Fistula

Intervention

Combination Product:
• Lutonix DCB

Device:
• Standard Balloon Angioplasty Catheter

Procedure:
• Percutaneous Transluminal Angiography
Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored.

Locations

Country	Name	City	State
United States	The Board of Trustees of The University of Alabama for the University of Alabama at Birmingham	Birmingham	Alabama
United States	Massachusetts General Physicians Organizations, Inc.	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Rush University	Chicago	Illinois
United States	Michigan Vascular Center	Flint	Michigan
United States	Tarrant Vascular Clinic	Fort Worth	Texas
United States	Board of Regents of the University of Wisconsin System	Madison	Wisconsin
United States	University Vascular Access	Memphis	Tennessee
United States	Minnesota Vascular Surgery Center	New Brighton	Minnesota
United States	Nephrology Associates, P.A.	Newark	Delaware
United States	RenalCare Associates, S.C. d/b/a Illinois Kidney Disease & Hypertension Center	Peoria	Illinois
United States	Trustees of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Arizona Kidney Disease and Hypertension Center Medical Research Services, LLC	Phoenix	Arizona
United States	Providence Interventional Associates, LLC	Providence	Rhode Island
United States	Capital Nephrology Associates, P.A.	Raleigh	North Carolina
United States	Capital Nephrology Medical Group	Sacramento	California
United States	San Antonio Kidney Disease Center Physicians Group, PLLC	San Antonio	Texas
United States	Spartanburg Regional Health Services District, Inc.	Spartanburg	South Carolina
United States	Renal and Transplant Associates of New England, PC	Springfield	Massachusetts
United States	Southwest Clinical Research Institute, LLC	Tempe	Arizona
United States	Oklahoma Life Access, PLLC	Tulsa	Oklahoma
United States	MakrisMD, LLC, d/b/a Chicago Access Care	Westmont	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
C. R. Bard

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Target Lesion Primary Patency (TLPP) at 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.	6 months post index procedure
Primary	Number of Participants With Freedom From Any Serious Adverse Event(s) Involving the AV Access Circuit at 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).	30 Days Post Index Procedure
Secondary	Percentage of Participants With Target Lesion Primary Patency at 3, 9, 12, 18, and 24 Months	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.	3, 9, 12, 18, and 24 Months Post Index Procedure
Secondary	Percentage of Participants With Device, Procedural and Clinical Success	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.	Device and Procedural Success: At time of Index Procedure; Clinical Success: at 1st session of dialysis following index procedure
Secondary	Number of Participants With Abandonment of Permanent Access in the Index Extremity at 3, 6, 9, 12, 18, and 24 Months Post Index Procedure	Index access site abandonment refers to an abandonment due to either receiving a kidney transplant, converting to Peritoneal Dialysis, or a new access site being created.	3, 6, 9, 12, 18 and 24 Months Post Index Procedure
Secondary	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
Secondary	Number of Participants With Device Related Adverse Events at 1, 3, 6, 9, 12, 18, and 24 Months (CEC Adjudicated)	Events adjudicated as 'definitely related' and 'possibly related' by the CEC were combined in all analyses and are displayed as 'related' in this report.	1, 3, 6, 9, 12, 18 and 24 Months Post Index Procedure
Secondary	Number of Participants With Target Lesion Primary Patency (TLPP) by Fiber Pre-Dilation Balloon at 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.	6 Months Post Index Procedure
Secondary	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
Secondary	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