Abstract | OBJECTIVES: To evaluate the safety and effectiveness of the Kaname™ cobalt- chromium (Co-Cr), thin strut, bare metal stent (BMS) system for the treatment of coronary artery lesions. BACKGROUND: METHODS: Two hundred eighty-two patients were enrolled in this prospective, single-arm study including a predefined subset of 79 patients with small vessels. The primary end-point was freedom from target vessel failure (TVF) at 6 months. Key angiographic and intravascular ultrasound (IVUS) end-points were late loss, diameter stenosis, binary restenosis, and neointimal hyperplasia volume. RESULTS: Freedom from TVF at 6 months was 93.3% and at 1 year 90.8% in total population, and 92.4% and 87.3% in small vessels, respectively. Clinically driven target lesion revascularization (TLR) rates at 6 and 12 months were 4.3% and 6.4% in total population, and 3.8% and 7.6% in small vessels, respectively. At 6 months in- stent late loss was 0.75 ± 0.43 mm and binary restenosis rate was 16.9% in total population, and 0.64 ± 0.40 mm and 26.1% in small vessels, while IVUS assessed neointimal hyperplasia volume at 6 months was 128.9 ± 42.6 mm(3) for total population. There were no definite and probable stent thromboses up to 12 months. CONCLUSIONS: Results indicate good safety and effectiveness of the Kaname™ stent with clinically equivalent results in small and larger vessels, as such providing useful treatment option for patients with ischemic heart disease considered for BMS implantation.
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Authors | Didier Carrie, Volker Schächinger, Gian Battista Danzi, Carlos Macaya, Uwe Zeymer, Biljana Putnikovic, Andres Iniguez, Raul Moreno, Zlatko Mehmedbegovic, Branko Beleslin, KARE INVESTIGATORS |
Journal | Journal of interventional cardiology
(J Interv Cardiol)
Vol. 27
Issue 5
Pg. 491-9
(Oct 2014)
ISSN: 1540-8183 [Electronic] United States |
PMID | 25175153
(Publication Type: Clinical Trial, Journal Article)
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Copyright | © 2014, Wiley Periodicals, Inc. |
Chemical References |
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Topics |
- Aged
- Angioplasty, Balloon, Coronary
- Chromium
- Cobalt
- Coronary Angiography
- Coronary Artery Disease
(therapy)
- Coronary Restenosis
(epidemiology)
- Female
- France
(epidemiology)
- Humans
- Hyperplasia
- Male
- Middle Aged
- Neointima
(pathology)
- Prospective Studies
- Stents
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