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 (<or= 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 <or= 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.