Clinical and Angiographic Outcomes after Tsunami™ Coronary Stent Placement

Study aim: The aim of this study was to determine six months restenosis rate measured by off-line quantitative coronary angiography, and to assess the efficacy and safety of newly developed six cells Tsunami™ stent system for the treatment of symptomatic, de novo, native coronary artery lesions. Study design and methods: Between January and August 2001, 100 patients with 120 lesions were included at four clinical sites in this prospective, non-randomized, single arm study. In 35% of the patients two or more stents were implanted, 15% of the lesions were stented with more than one stent and 46% of the lesions were in small vessels (≤ 2.75 mm). The Tsunami™ stent was available in 10, 15, 20 and 30 mm, length, and 3, 3.5 and 4 mm diameter. Angiographic success rate for stented lesions was 100% (residual diameter stenosis ≤ 30%) and procedural success rate was 98%. Mean reference vessel diameter by QCA was 2.83 ± 0.52, and post-procedural minimal lumen diameter was 2.59 ± 0.4. Six months angiographic follow-up was available for 81% of the patients and revealed an in-stent restenosis rate of 13.8% for all lesions and 7.4% for single stented lesions. At 30 days 98% and at 6 months 88% of the patients remained free of major adverse cardiac events. Conclusion: Based on the clinical and angiographic results of the present study we can conclude that the Tsunami™ stent provides safe and effective percutaneous treatment of obstructive coronary artery disease.