Physician

Ellen Redstone, MD

Study Coordinator

Danielle Schneider
email: Danielle.Schneider@sluhn.org
phone: 484-658-4982

 

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To demonstrate safety and assess the clinical use and outcomes of the LUTONIXTM DCB for treatment of dysfunctional AV fistulae located in the arm in a heterogeneous patient population in real world clinical practice.

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1. Male or non-pregnant, non-breastfeeding female ≥18 years of age;
2. Subject is willing to provide informed consent, and is willing to co ply 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 LUTONIXTM 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:
   • a) No clinically significant dissection;
   • b) No extravasation requiring treatment;
   • c) Residual stenosis ≤30% by angiographic measurement;
   • d) Ability to completely efface the waist using the pre-dilation balloon.

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