This study evaluated delivery performance, quantitative angiographic parameters, intravascular ultrasound appearance. long term patency and vascular histology of radio-opaque, slotted-tube nickel titanium (nitinoll stents permanently implanted in canine coronary arteries. Dogs were treated with aspirin for 1 month. Follow-up angiography and histology were performed at 0.5, 1, 3, and 6 months (number of vessels = 2, 4, 6, and 26, respectively). Thirty-eight of 39 (97%) stents were successfully implanted in the mid LAD and LCX of 20 dogs. One stent, which was undersized, was successfully removed by thermal recovery. Tandem stents were placed in 2 dogs without difficulty. Intravascular ultrasound of 6 stents showed symmetrical expansion with good wall contact. Acute angiographic parameters: nominal stent size (mm) ANOVA p 3.0 3.5 4.0 number 4 22 12 – inflation pressure (atm) 5.5 ± 05 6.1 ± 1.4 5.9 ± 1.6 0.47 minimal diameter (mm) 2.93 ± 0.07 3.24 ± 0.14 3.48 ± 0.16 0.0003 balloon to artery ratio 1.23 ± 0.03 1.25 ± 0.10 1.25 ± 0.08 0.65 stent to artery ratio 1.09 ± 0.03 1.14 ± 0.09 1.13 ± 0.07 0.30 percent recoil 11.0 ± 1.8 8.4 ± 1.8 9.9 ± 1.8 0.05 At follow-up, all vessels and 9 of 9 stented sidebranches were patent. The mean percent stenosis at 3 to 6 months was –1.6 ± 5.2 and the late loss was 0.2 ± 0.3 mm. All struts were covered with neointima at 2 weeks. At 6 months the maximal neointimal thickness was 260 ± 50 μ m and was located adjacent to the struts. No thrombi and only occasional areas of granulation tissue with rare inflammatory cells were seen. A slotted tube nitinol stent has delivery performance characteristics and recoil similar to stainless steel slotted-tube stents. Nitinol stents endothelialize rapidly and intimal proliferation is insufficient to create a stenosis in this animal model. These data suggest that a slotted-tube, balloon expandable nitinol stent is sufficiently reliable and biocompatible to warrant clinical trials.
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