None listed
Conditions
Brief summary
The purpose of this study is to assess the safety and performance of the Cook Advance Scoring Balloon in treating narrowed blood vessels to improve the effectiveness of haemodialysis treatments.
Interventions
The Advance Scoring Balloon is a balloon catheter used to perform angioplasty in narrowed blood vessels. In this study it is used to treat narrowing of a hemodialysis fistula in order to improve the effectiveness of dialysis. Angiography and intravascular ultrasound will be used during the procedure to examine the effectiveness of the study procedure. The procedure should take approximately 45 minutes. After the procedure, participants are required to complete follow-up visits at 1, 3, and 6 mon
The Advance Scoring Balloon is a balloon catheter used to perform angioplasty in narrowed blood vessels. In this study it is used to treat narrowing of a hemodialysis fistula in order to improve the effectiveness of dialysis. Angiography and intravascular ultrasound will be used during the procedure to examine the effectiveness of the study procedure. The procedure should take approximately 45 minutes. After the procedure, participants are required to complete follow-up visits at 1, 3, and 6 months to undergo clinical assessment. An angiogram will also be performed at 3 and 6 months post-procedure.
Sponsors
Cook Incorporated
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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
Outcome results
None listed