Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

More Details

Status
Recruiting
Sponsor
C. R. Bard

Study Contact

Bradley Forsyth, MBA
385-583-9259
bradley.forsyth@bd.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.