Trial Details

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

NCT03506308

RECRUITING

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.

CONDITIONS

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.