The objective of this prospective, multicenter, observational trial was to evaluate the procedural results and longterm outcomes of the flexible AVE GFX coronary stent in native coronary lesions. The trial included 137 consecutive patients (111 [81%] men, age 63.1 +/- 9.2 years) with one vessel disease (n = 76 [55.5%]), two vessel disease (n = 31 [22.6%]), and three vessel disease (n = 30 [21.9%]) with ischemia secondary to a significant denovo lesion (diameter > or = 3 mm, length < or = 18 mm) in a native coronary artery. Stent deployment was successful in 97.8% (134/137) of patients. Angiographic follow-up at 6.1 +/- 1.2 months was available in 111 (82.8%) of 134 patients. All angiographic images were analyzed by an independent core lab. The primary end point was the binary restenosis rate. In-hospital major cardiac events occurred in 3.7%. No postdischarge major adverse cardiac events occurred, except for one abrupt closure (0.7%). Angiographic restenosis was documented in 22 (19.8%) of 111 patients. The GFX stent is easy to handle with high success and low restenosis rates in patients with simple lesions in native coronary arteries and, thus, compares favorably with other sophisticated stents.
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