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Clinical Trials/ACTRN12614000094673
ACTRN12614000094673Completed未知

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:
Conditions

Trial Snapshot

Phase
未知
Status
Completed
Enrollment
30

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional
Allocation
Non-randomised trial
Primary Purpose
Treatment

Eligibility Criteria

Ages
18 Years to o limit (—)
Sex
All

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

Investigators

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