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

NCT02440022 | Completed Phase 3 Results DMC

• 1 other identifier: CL0023-01
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 23

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.

Conditions

Arteriovenous Fistula

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• 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

• 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 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 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

Study Arms (2)

Lutonix DCB

EXPERIMENTAL

Percutaneous transluminal angiography (PTA) will be performed using the Lutonix AV drug coated balloon.

Combination Product: Lutonix DCB; Procedure: Percutaneous Transluminal Angiography

Standard Balloon Angioplasty Catheter

ACTIVE COMPARATOR

Percutaneous transluminal angiography (PTA) will be performed using a commercially available uncoated PTA balloon. Balloons with an external wire support, cutting/scoring component or other similar modifications are not permitted. Multiple balloons, inflations and/or prolonged inflation may be used.

Device: Standard Balloon Angioplasty Catheter; Procedure: Percutaneous Transluminal Angiography

Interventions

Lutonix DCB COMBINATION_PRODUCT

Lutonix DCB

Standard Balloon Angioplasty Catheter DEVICE

Standard Balloon Angioplasty Catheter

Percutaneous Transluminal Angiography PROCEDURE

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.

Also known as: PTA

Lutonix DCB; Standard Balloon Angioplasty Catheter

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Known contraindication (including allergic reaction) or sensitivity to iodinated contrast media, that cannot be adequately managed with pre-and post-procedure medication;
• Known contraindication (including allergic reaction) or sensitivity to paclitaxel.
• Subjects who are taking immunosuppressive therapy or are routinely taking
• ≥10mg of prednisone per day;
• 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;

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (23)

The Board of Trustees of The University of Alabama for the University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Arizona Kidney Disease and Hypertension Center Medical Research Services, LLC

Phoenix, Arizona, 85012, United States

Location

Southwest Clinical Research Institute, LLC

Tempe, Arizona, 85284, United States

Location

Capital Nephrology Medical Group

Sacramento, California, 95825, United States

Location

Nephrology Associates, P.A.

Newark, Delaware, 19713, United States

Location

Rush University

Chicago, Illinois, 60612, United States

Location

RenalCare Associates, S.C. d/b/a Illinois Kidney Disease & Hypertension Center

Peoria, Illinois, 61603, United States

Location

MakrisMD, LLC, d/b/a Chicago Access Care

Westmont, Illinois, 60559, United States

Location

Massachusetts General Physicians Organizations, Inc.

Boston, Massachusetts, 02114, United States

Location

Renal and Transplant Associates of New England, PC

Springfield, Massachusetts, 01107, United States

Location

Michigan Vascular Center

Flint, Michigan, 48507, United States

Location

Minnesota Vascular Surgery Center

New Brighton, Minnesota, 55112, United States

Location

Capital Nephrology Associates, P.A.

Raleigh, North Carolina, 27610, United States

Location

Oklahoma Life Access, PLLC

Tulsa, Oklahoma, 74104, United States

Location

Trustees of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Providence Interventional Associates, LLC

Providence, Rhode Island, 02906, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Spartanburg Regional Health Services District, Inc.

Spartanburg, South Carolina, 29303, United States

Location

University Vascular Access

Memphis, Tennessee, 38115, United States

Location

Tarrant Vascular Clinic

Fort Worth, Texas, 76104, United States

Location

San Antonio Kidney Disease Center Physicians Group, PLLC

San Antonio, Texas, 78215, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Board of Regents of the University of Wisconsin System

Madison, Wisconsin, 53715, United States

Location

Related Publications (1)

• Trerotola SO, Lawson J, Roy-Chaudhury P, Saad TF; Lutonix AV Clinical Trial Investigators. Drug Coated Balloon Angioplasty in Failing AV Fistulas: A Randomized Controlled Trial. Clin J Am Soc Nephrol. 2018 Aug 7;13(8):1215-1224. doi: 10.2215/CJN.14231217. Epub 2018 Jul 24.

  PMID: 30042225 DERIVED

MeSH Terms

Conditions

Arteriovenous Fistula

Condition Hierarchy (Ancestors)

Arteriovenous Malformations; Vascular Malformations; Cardiovascular Abnormalities; Cardiovascular Diseases; Vascular Fistula; Vascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Heidi Ronhovde
• Organization: Becton Dickinson (BD)

Heidi.Ronhovde@bd.com

480-597-8579

Study Officials

• Scott Trerotola, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2015
• First Posted: May 12, 2015
• Study Start: June 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: June 1, 2018
• Last Updated: May 6, 2020
• Results First Posted: May 6, 2020

Record last verified: 2020-04

Locations

US (23)