Clinical trial NCT03506308: Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arteriovenous Fistula
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2018-04-24
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Target Lesion Primary Patency (TLPP)
timeFrame: 6 Months
measure: Percentage of Participants With No Primary Safety Events
timeFrame: 30 days
Secondary outcomes:
measure: Percentage of Participants With Target Lesion Primary Patency
timeFrame: 12, 18, 24 Months
measure: Number of re-interventions required to maintain target lesion patency
timeFrame: 6, 12, 18, 24 Months
measure: Percentage of Participants With Access Circuit Primary Patency (ACPP)
timeFrame: 6, 12, 18, 24 Months
measure: Number of re-interventions required to maintain access circuit patency
timeFrame: 6, 12, 18, 24 Months
measure: Percentage of Participants With Device, Procedural, and Clinical Success
timeFrame: 24 Months
measure: Percentage of Participants With Abandonment of Permanent Access in the Index Extremity
timeFrame: 6, 12, 18, 24 Months
measure: Percentage of Participants With Secondary Patency of the Access Circuit
timeFrame: 6, 12, 18, 24 Months
measure: Time to loss of target lesion secondary patency following DCB intervention
timeFrame: 24 Months
measure: Percentage of Participants With Freedom from any Serious Adverse Event(s) Involving the AV Access Circuit
timeFrame: 6, 12, 18, 24 Months
measure: Percentage of Participants With Device and Procedure Related Adverse Events
timeFrame: 6, 12, 18, 24 Months
Other outcomes:
measure: Vital status of participants
timeFrame: 36, 48, and 60 Months
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Dothan
country: United States
facility: Flowers Hospital
state: Alabama
city: Orange
country: United States
facility: St. Joseph Hospital of Orange
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics
state: Iowa
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Health System
state: Louisiana
city: Shreveport
country: United States
facility: Ochsner Louisiana State University Health
state: Louisiana
city: Annapolis
country: United States
facility: MedStar Health Research Institute
state: Maryland
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: Dallas Vascular Center
state: Texas
city: Houston
country: United States
facility: HCA Houston Healthcare
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Norfolk
country: United States
facility: Sentara Medical Group
state: Virginia
city: Brampton
country: Canada
facility: William Osler Health System/Brampton Civic Hospital
state: Ontario
city: Scarborough
country: Canada
facility: Scarborough Health Network
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montreal
state: Quebec
Study officials:
affiliation: Hospital of the University of Pennsylvania; Division of Interventional Radiology
name: Scott Trerotola, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Health Network; Division of Vascular & Interventional Radiology
name: Dheeraj Rajan, MD
role: PRINCIPAL_INVESTIGATOR
References: