Direct stent implantation using the EXPRESS Coronary Stent System: results of a multi-center feasibility study.
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Abstract The aim of this prospective, multicenter, single arm study was to assess the safety and feasibility of EXPRESS Coronary Stent implantation in native coronary arteries without balloon predilatation. Forty-two patients with de novo or restenotic lesions were enrolled, of which 38 were eligible for analysis. The coronary lesions were predominantly complex, occurring in arteries with a mean reference diameter of 2.80 +/- 0.49 mm. Technical and procedural success were achieved in 89.5% and 84% of the cases respectively. The mean minimal lumen diameter increased from 1.08 +/- 0.26 mm to 2.55 +/- 0.44 mm and diameter stenosis decreased from 61 +/- 7% to 13 +/- 8%. The primary endpoint of major adverse cardiac events at 30 days was 2.6% and was limited to only one event (target vessel revascularization, nontarget lesion). No other MACE were observed during the three-month follow-up period. Based on the findings of this study, direct stenting with the EXPRESS Stent appears feasible and is well tolerated.
- Follow-Up Studies
- Prospective Studies
- Treatment Outcome
- Coronary Angiography
- Equipment Design
- Feasibility Studies
- Myocardial Revascularization
- Angioplasty, Balloon, Coronary
- Coronary Stenosis/complications/radiography/*therapy
- Coronary Restenosis/etiology/*prevention & control/radiography
- Myocardial Infarction/etiology/*prevention & control/radiography