RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2018-08-07

Study Completion:2029-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03506308

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Bradley Forsyth, MBA

CONTACT

385-583-9259

bradley.forsyth@bd.com

Anna Lovas

CONTACT

(763) 445-2385

anna.lovas@bd.com

Principal Investigator

Scott Trerotola, MD

PRINCIPAL_INVESTIGATOR

Hospital of the University of Pennsylvania; Division of Interventional Radiology

Dheeraj Rajan, MD

PRINCIPAL_INVESTIGATOR

University Health Network; Division of Vascular & Interventional Radiology

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35233

United States

Flowers Hospital

Dothan, Alabama, 36305

United States

St. Joseph Hospital of Orange

Orange, California, 92868

United States

Kaiser Permanente

San Diego, California, 92123

United States

Yale University

New Haven, Connecticut, 06520

United States

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242

United States

University of Louisville

Louisville, Kentucky, 40202

United States

Ochsner Health System

New Orleans, Louisiana, 70121

United States

Ochsner Louisiana State University Health

Shreveport, Louisiana, 71103

United States

MedStar Health Research Institute

Annapolis, Maryland, 21401

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

University of Minnesota

Minneapolis, Minnesota, 55455

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Columbia University Medical Center

New York, New York, 10032

United States

Rochester General Hospital

Rochester, New York, 14621

United States

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033

United States

Dallas Vascular Center

Dallas, Texas, 75208

United States

HCA Houston Healthcare

Houston, Texas, 77004

United States

Houston Methodist Hospital

Houston, Texas, 77030

United States

University of Texas Health Science Center

Houston, Texas, 77030

United States

Sentara Medical Group

Norfolk, Virginia, 23507

United States

Collaborators and Investigators

Sponsor: C. R. Bard

Scott Trerotola, MD, PRINCIPAL_INVESTIGATOR, Hospital of the University of Pennsylvania; Division of Interventional Radiology
Dheeraj Rajan, MD, PRINCIPAL_INVESTIGATOR, University Health Network; Division of Vascular & Interventional Radiology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-08-07

Study Completion Date2029-09

Study Record Updates

Study Start Date2018-08-07

Study Completion Date2029-09

Terms related to this study

Additional Relevant MeSH Terms

Arteriovenous Fistula