Clinical Evaluation of the Advance (Registered Trademark) 35 Scoring Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter in treating stenoses of a mature native arteriovenous (AV) hemodialysis access circuit

Cook Incorporated0 sites30 target enrollmentStarted: January 24, 2014Last updated: January 13, 2020

Conditions

Trial Snapshot

No summary available.

•1. A greater than 50% stenosis (when compared to the reference vessel diameter) of a mature native AV dialysis access circuit in the upper extremity
•2. Clinical or physiological abnormalities which indicate dialysis access dysfunction

•1. Any related surgical or interventional procedure of the access circuit less than or equal to 30 days prior to the enrollment
•2. Medical condition or comorbid conditions that would limit life expectancy to less than 6 months
•3. Scheduled for a kidney transplant
•4. Known hypersensitivity or contraindication to contrast agent that, in the opinion of the investigator, cannot be adequately pre-medicated
•5. Synthetic AV dialysis access graft
•6. Current or previous history of thrombosis anywhere within the AV dialysis access circuit
•7. Evidence of systemic or local infection associated with the AV dialysis access circuit
•8. History of bleeding diathesis or coagulopathy or will refuse blood transfusions
•9. Stent or stent graft in the AV dialysis access circuit
•10. Hemodynamically significant central venous stenosis, unless successfully treated prior to treating the study lesion
•11. Presence of occlusion in the AV dialysis access circuit such that a guidewire cannot pass through the lesion
•12. Target lesion is greater than or equal to 4 cm in length
•13. Reference vessel diameter is greater than 12 mm
•14. Presence of more than two distinct lesions (stenoses) in the AV dialysis access circuit

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