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

A Prospective, Global, Multicenter, Single Arm Post-Approval Study Investigating the Clinical Use and Safety of the Lutonix® Drug Coated Balloon PTA Catheter for the Treatment of Dysfunctional AV Fistulae

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Arteriovenous Fistula
• Intervention / Treatment: Device: LUTONIX 035 Drug Coated Balloon PTA Catheter

Detailed Description

This post-market approval study (PAS) is required by the FDA as a condition of approval for the Lutonix drug coated balloon catheter. It is intended to demonstrate safety and assess the clinical use and outcomes of the LUTONIX Catheter in dysfunctional arteriovenous fistulae (AVF) in a heterogeneous patient population in real world clinical practice.

• Study Type: Interventional
• Enrollment (Estimated): 213
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Brampton, Ontario, Canada, L6R 3J7
      • William Osler Health System/Brampton Civic Hospital
    • Scarborough Village, Ontario, Canada, M1P 2V5
      • Scarborough Health Network
    • Toronto, Ontario, Canada, M5G 1Z5
      • University Health Network
  • Quebec
    • Montreal, Quebec, Canada, H2X 0C1
      • Centre Hospitalier de l'Université de Montréal
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
    • Dothan, Alabama, United States, 36305
      • Flowers Hospital
  • California
    • Orange, California, United States, 92868
      • St. Joseph Hospital of Orange
    • San Diego, California, United States, 92123
      • Kaiser Permanente
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospital and Clinics
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Health System
    • Shreveport, Louisiana, United States, 71103
      • Ochsner Louisiana State University Health
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Medstar Health Research Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
    • Rochester, New York, United States, 14621
      • Rochester General Hospital
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Health Milton S. Hershey Medical Center
  • Texas
    • Dallas, Texas, United States, 75208
      • Dallas Vascular Center
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center
    • Houston, Texas, United States, 77004
      • HCA Houston Healthcare
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or non-pregnant, non-breastfeeding female ≥18 years of age
2. Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits
3. 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
4. Subject has a target lesion that can be treated with available LUTONIX DCB according to the Instructions For Use (IFU)
5. 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

6. Successful pre-dilation of the target lesion with an uncoated percutaneous transluminal angioplasty (PTA) balloon defined as:

   1. No clinically significant dissection;
   2. No extravasation requiring treatment;
   3. Residual stenosis ≤30% by angiographic measurement;
   4. Ability to completely efface the waist using the pre-dilation balloon.

Exclusion Criteria:

1. Subject is currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study
2. Subject has a non-controllable allergy to contrast
3. 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
4. Target lesion is located central to the axillosubclavian junction
5. A thrombosed access or an access with a thrombosis treated ≤7 days before to the index procedure
6. Prior surgical interventions of the access site ≤30 days before the index procedure
7. Target lesion is located within a bare metal or covered stent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: LUTONIX 035 Drug Coated Balloon PTA Catheter; 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; All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Target Lesion Primary Patency	TLPP is defined as the interval following index procedure intervention until clinically driven reintervention of the target lesion or access thrombosis.	12, 18, 24 Months
Number of re-interventions required to maintain target lesion patency	Clinically driven reintervention is defined as a lesion that has ≥ 50% stenosis and at least one clinical, physiological or hemodynamic abnormality attributable to the stenosis defined in the K/DOQI guidelines.	6, 12, 18, 24 Months
Percentage of Participants With Access Circuit Primary Patency (ACPP)	Access circuit is defined as the area from the AV access anastomosis to the superior vena cava-right atrial junction.	6, 12, 18, 24 Months
Number of re-interventions required to maintain access circuit patency	Clinically driven reintervention is defined as a lesion that has ≥ 50% stenosis and at least one clinical, physiological or hemodynamic abnormality attributable to the stenosis defined in the K/DOQI guidelines.	6, 12, 18, 24 Months
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.	24 Months
Percentage of Participants With Abandonment of Permanent Access in the Index Extremity	The arteriovenous fistula / access circuit is considered abandoned when it is no longer being used for dialysis because the access was not functioning.	6, 12, 18, 24 Months
Percentage of Participants With Secondary Patency of the Access Circuit	Survival of patency of access circuit from the time of intervention until access abandonment or achievement of a censored event (death, transfer to another hemodialysis unit, transfer to peritoneal dialysis, transplantation, and end of study period), and includes all surgical and endovascular interventions.	6, 12, 18, 24 Months
Time to loss of target lesion secondary patency following DCB intervention	Time between first reintervention with the DCB to the next loss of patency	24 Months
Percentage of Participants With Freedom from any Serious Adverse Event(s) Involving the AV Access Circuit	Safety events include any serious adverse event(s) involving the AV access circuit	6, 12, 18, 24 Months
Percentage of Participants With Device and Procedure Related Adverse Events	Freedom from device-related or procedure-related serious adverse events	6, 12, 18, 24 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital status of participants	All cause death	36, 48, and 60 Months

Collaborators and Investigators

• Sponsor: C. R. Bard
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2018
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: April 14, 2018
• First Submitted That Met QC Criteria: April 14, 2018
• First Posted (Actual): April 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Congenital Abnormalities; Cardiovascular Abnormalities; Vascular Malformations; Fistula; Arteriovenous Malformations; Vascular Fistula; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Arteriovenous Fistula
• Other Study ID Numbers: CL0033-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes