Objective: To compare the results of stent graft placement to balloon angioplasty for the treatment of stenosis at the venous anastomosis of failing and thrombosed prosthetic hemodialysis grafts.
Methods: This prospective, multicenter trial included 293 patients randomized (1:1) to the stent graft (n = 145) or balloon angioplasty (n = 148) group for treatment of stenosis at the venous anastomosis of dysfunctional (n = 164) or thrombosed (n = 129) hemodialysis grafts. The primary study end point was target lesion primary patency at 6 months; participants were followed for up to 24 months.