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Multicenter evaluation of a new fixed-wire coronary angioplasty catheter system: Clinical and angiographic characteristics and results
Authors:J David Talley  Abraham Joseph  Eugene S Killeavy  Kirk N Garratt  Z I Hodes  T J Linnemeier  Zoe Ann Yussman  Michael E Brier  Joel Kupersmith
Abstract:Coronary angioplasty is increasingly used as an attempt to revascularize patients with severe coronary artery disease. To determine the efficacy of such treatment, a new fixed wire angioplasty catheter was evaluated by a multicenter group in a non-randomized fashion in 50 patients, average 58 ± 11 years (± 1SD), 58% men. Forty-four percent had a prior revascularization procedure (28% angioplasty, 16% coronary bypass surgery), 38% had a prior Q-wave myocardial infarction, 43% had grade 4 angina, and 60% multiple vessel disease. Angioplasty was attempted in 63 lesions which were located in a mid to distal location in 69%, with a proximal tortuosity score of 1.8 (2 = 45–60° entrance angle), and lesion angulation of 1.4 (1 = 45° lesion bend). In 88%, the device was the primary catheter used and in 6%, it was chosen when another system failed. The balloon was able to successfully cross 94% of all lesions attempted. Six lesions were crossed and dilated but significant residual stenoses remained. There were no significant device malfunctions, or angiographic or clinical complications. This feasibility evaluation of this new fixed wire system yielded excellent angiographic results. Although not a comparative study, this analysis suggests that this new generation of angioplasty catheter may improve the safety and efficacy of complex coronary angioplasty.
Keywords:balloon catheter  coronary artery disease  coronary angiography  angioplasty  equipment design  percutaneous transluminal coronary angioplasty
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