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Sapoval, M. et al.

Sapoval, Zähringer, Pattynama, Rabbia, Vignali, Maleux, Boyer, Szczerbo-Trojanowska, Jaschke, Hafsahl, Downes, Beregi, Veeger, Talen,

Low-profile stent system for treatment of atherosclerotic renal artery stenosis: the GREAT trial.

PURPOSE: The Palmaz Genesis Peripheral Stainless Steel Balloon Expandable Stent in Renal Artery Treatment (GREAT) Trial was designed to assess the safety and performance of a low-profile stent for the treatment of obstructive renal artery disease by looking at 6-month renal artery patency uniformly analyzed by a Core Lab. MATERIALS AND METHODS: Fifty-two consecutive patients (mean age, 63.7 years) were successfully treated with the Palmaz Genesis Peripheral Stent (Cordis, Miami, FL) on the Slalom 0.018-inch Delivery System (Cordis Europe N.V., Oosteinde 8, NLO-9301 LJ Roden, The Netherlands) at 11 investigational centers. Patients with severe renal failure and > 8-mm renal artery were excluded. Primary endpoint was angiographic determination of in-stent percent diameter stenosis at 6 months. Fifty-one patients were treated with one stent, one patient was treated with two stents to cover the complete lesion. RESULTS: Mean percentage diameter stenosis before renal angioplasty was 68.2% +/- 12.0%. No stent implantation failure, displacement, need for additional stent implantation, or procedural complication was observed. Six-month angiography was performed in 41 of 52 patients (79%) resulting in a mean in-stent percent diameter stenosis or Quantitative Vessel analysis (QVA) at 6 months of 23.9%. The in-stent binary (percent diameter stenosis > 50%) restenosis rate at 6 months was 14.3%. No fatal events occurred up to 6 months after implantation. Major adverse events occurred in five patients: four patients (7.7%) required a revascularization and one patient (1.9%) experienced a cerebrovascular event, which regressed spontaneously. CONCLUSIONS: The Palmaz Genesis stent (Cordis) provides good results for renal artery stent placement, with an in-stent binary restenosis rate (percent diameter stenosis > 50%) at 6 months of 14.3% as determined with angiography.[1]

References

Low-profile stent system for treatment of atherosclerotic renal artery stenosis: the GREAT trial. Sapoval, M., Zähringer, M., Pattynama, P., Rabbia, C., Vignali, C., Maleux, G., Boyer, L., Szczerbo-Trojanowska, M., Jaschke, W., Hafsahl, G., Downes, M., Beregi, J.P., Veeger, N., Talen, A. Journal of vascular and interventional radiology : JVIR. (2005) [Pubmed]

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