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

Launched by C. R. BARD · Apr 14, 2018

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a special balloon called the Lutonix® Drug Coated Balloon, which is used to treat problems in arteriovenous (AV) fistulas. AV fistulas are connections made between an artery and a vein, often used for dialysis in patients with kidney issues. The study is open to adults aged 18 and older who have a mature AV fistula in their arm that is not functioning well, and who meet specific health criteria. Participants must agree to follow up with the study team after the procedure.

If you qualify and choose to participate, you will undergo a procedure where the Lutonix balloon will be used to help improve blood flow in your AV fistula. This study is currently recruiting participants, and it's important to know that your health will be monitored closely throughout the process. If you're interested, the study team will provide more details and answer any questions you may have to help you make an informed decision.

Gender

ALL

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