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Clinical Trial Summary

The narrowing of Dialysis Fistulae or Grafts is a near universal problem in patients with end-stage renal disease (ESRD) and requires patients to undergo repeated angioplasty or mechanical opening of the fistula.


Clinical Trial Description

The failure of dialysis accesses remains a leading cause of morbidity and medical costs among ESRD subjects. The underlying etiology for dialysis access failure is uniformly due to progressive narrowing of the vessel lumen leading to stasis and thrombosis of the access. The luminal narrowing of arteriovenous fistulae (AVFs) is due to progressive hyperplasia of vessel intima and subsequent infiltration of smooth muscle cells into the vessel media. Areas of stenosis within AVFs are characterized by dense neointimal hyperplasia, infiltration of vascular smooth muscle cells and expansion of extracellular matrix material. Additionally, varying types of vascular injury increase the rate of collagen and elastin deposition within the medial and serosal areas of the vessel. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03106948
Study type Interventional
Source Southeast Renal Research Institute
Contact James A Tumlin, MD
Phone 423-290-0882
Email jamestumlinmd@nephassociates.com
Status Recruiting
Phase Phase 2
Start date February 1, 2017
Completion date March 2018

See also
  Status Clinical Trial Phase
Recruiting NCT04543539 - IN.PACTâ„¢ AV Access Post-Approval Study (PAS002)
Completed NCT05832476 - O-GlcNac Modified Proteomics Study of the Maturation of Hemodialysis Arteriovenous
Completed NCT03041467 - IN.PACTâ„¢ AV Access IDE Study N/A