Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae

NCT03506308 | Active Not Recruiting FDA Device

• 1 other identifier: CL0033-01
• Study Type: interventional
• Target: 213
• Locations: 2 countries
• Sites: 26

Brief Summary

This prospective, global, multicenter, single arm post-approval study is designed to investigate the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter in 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)

  TLPP is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis.

  6 Months

• Percentage of Participants With No Primary Safety Events

  Primary safety events include any serious adverse event(s) involving the AV access circuit through 30 days

  30 days

Secondary Outcomes (10)

• Percentage of Participants With Target Lesion Primary Patency

  12, 18, 24 Months

• Number of re-interventions required to maintain target lesion patency

  6, 12, 18, 24 Months

• Percentage of Participants With Access Circuit Primary Patency (ACPP)

  6, 12, 18, 24 Months

• Number of re-interventions required to maintain access circuit patency

  6, 12, 18, 24 Months

• Percentage of Participants With Device, Procedural, and Clinical Success

  24 Months

Other Outcomes (1)

• Vital status of participants

  36, 48, and 60 Months

Study Arms (1)

LUTONIX 035 Drug Coated Balloon PTA Catheter

OTHER

This is a single-arm study. All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.

Device: LUTONIX 035 Drug Coated Balloon PTA Catheter

Interventions

LUTONIX 035 Drug Coated Balloon PTA Catheter DEVICE

All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.

LUTONIX 035 Drug Coated Balloon PTA Catheter

Eligibility Criteria

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

You may qualify if:

• Male or non-pregnant, non-breastfeeding female ≥18 years of age
• Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits
• Target lesion must be a mature arteriovenous fistula located in the arm presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines
• Subject has a target lesion that can be treated with available LUTONIX DCB according to the Instructions For Use (IFU)
• Venous stenosis of an AV fistula in which the target lesion is located from the anastomosis to the axillosubclavian junction, as defined by insertion of the cephalic vein
• Successful pre-dilation of the target lesion with an uncoated percutaneous transluminal angioplasty (PTA) balloon defined as:
• No clinically significant dissection;
• No extravasation requiring treatment;
• Residual stenosis ≤30% by angiographic measurement;
• Ability to completely efface the waist using the pre-dilation balloon.

You may not qualify if:

• Subject is currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study
• Subject has a non-controllable allergy to contrast
• Subject has another medical condition that, in the opinion of the Investigator, may confound the data interpretation or is associated with a life expectancy insufficient to allow for completion of subject study procedure and follow up
• Target lesion is located central to the axillosubclavian junction
• A thrombosed access or an access with a thrombosis treated ≤7 days before to the index procedure
• Prior surgical interventions of the access site ≤30 days before the index procedure
• Target lesion is located within a bare metal or covered stent

Sponsors & Collaborators

• C. R. Bard: lead

Study Sites (26)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Flowers Hospital

Dothan, Alabama, 36305, United States

Location

St. Joseph Hospital of Orange

Orange, California, 92868, United States

Location

Kaiser Permanente

San Diego, California, 92123, United States

Location

Yale University

New Haven, Connecticut, 06520, United States

Location

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Ochsner Health System

New Orleans, Louisiana, 70121, United States

Location

Ochsner Louisiana State University Health

Shreveport, Louisiana, 71103, United States

Location

MedStar Health Research Institute

Annapolis, Maryland, 21401, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Rochester General Hospital

Rochester, New York, 14621, United States

Location

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Dallas Vascular Center

Dallas, Texas, 75208, United States

Location

HCA Houston Healthcare

Houston, Texas, 77004, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

Sentara Medical Group

Norfolk, Virginia, 23507, United States

Location

William Osler Health System/Brampton Civic Hospital

Brampton, Ontario, L6R 3J7, Canada

Location

Scarborough Health Network

Scarborough Village, Ontario, M1P 2V5, Canada

Location

University Health Network

Toronto, Ontario, M5G 1Z5, Canada

Location

Centre hospitalier de l'Université de Montreal

Montreal, Quebec, H2X 0C1, Canada

Location

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

Study Officials

• Scott Trerotola, MD

  Hospital of the University of Pennsylvania; Division of Interventional Radiology

  PRINCIPAL INVESTIGATOR

• Dheeraj Rajan, MD

  University Health Network; Division of Vascular & Interventional Radiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2018
• First Posted: April 24, 2018
• Study Start: August 7, 2018
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2030
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4); US (22)