A Phase 3, Randomized, Multicenter, Single-blind Controlled Study evaluating Arteriovenous fistula outcomes with and without a Perivascular Sirolimus-eluting collagen Implant (The ACCESS Trial) Save

Date Added
April 15th, 2016
PRO Number
Pro00048577
Researcher
Thomas Powell
Keywords
Kidney, Surgery
Summary

Subjects of either gender, who are at least 18 years of age, undergoing hemodialysis or those expected to start dialysis within 6 months, and require a new single-stage radiocephalic or brachiocephalic end-to-side fistula will be eligible to participate in this study. Subjects who meet eligibility criteria and undergo successful AV fistula creation (i.e., a patent fistula confirmed by the presence of a thrill and bruit with satisfactory hemostasis) will be eligible for enrollment. The number of planned patients enrollment to 180 ? 240, subjects to be randomized to 160 ? 220 with a yield of approximately 150 ? 200 noting that the randomized cohort will include a minimum of 100 evaluable subjects who are on hemodialysis at the time of index procedure. Evaluations to determine fistula suitability for cannulation will start no earlier than day 28 post index procedure and will continue to least weekly. All enrolled subjects will be followed for a period of one year from the time of their index procedure.

Institution
Palmetto
Recruitment Contact
Michelle Hardin
803-252-9907 ext 247
mhardin@columbianephrology.com

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