The purpose of this study was to determine the frequency and predictors of major in-hospital ischemic complications after planned and unplanned procedures with new angioplasty devices from the New Approaches to Coronary Intervention (NACI) registry. The NACI registry is a multicenter, voluntary reporting of consecutive patients undergoing new-device angioplasty procedures using atherectomy catheters, stents, or lasers. This registry affords the opportunity to evaluate the performance of new angioplasty devices during elective and urgent circumstances. The study population consisted of 3,340 patients with 3,733 lesions (2,921 in native coronary arteries and 812 in saphenous vein grafts [SVGs], who were treated with new devices over a 3.5-year period and had their angiograms analyzed independently at a central angiographic core laboratory. Their in-hospital course and multivariate predictors of the complications in planned and unplanned procedures, further divided into native and SVG lesions, were evaluated. In 82.2% of native coronary artery lesions and 96.9% of SVG lesions, the procedure with a device had been planned due to unfavorable lesion characteristics for PTCA. In the remaining lesions, device use was unplanned, and was performed mainly to treat a suboptimal result (59-80.4%) after percutaneous transluminal coronary angioplasty (PTCA), and less frequently after important complications of PTCA including abrupt closure and PTCA failure. In native artery cohort, major in-hospital ischemic complications (death, Q-wave myocardial infarction [MI], or emergency coronary artery bypass surgery) occurred in 2.7% of the planned and 9.9% of the unplanned procedures (p < 0.001), whereas in SVG such complications occurred in 3.6% of the planned and 8.7% of unplanned procedures (p = 0.21). Multivariate analysis revealed several predictors of major ischemic complications from planned native coronary artery device use: post-MI angina (odds ratio = 2.83); severe concomitant noncardiac disease (odds ratio = 2.5); multivessel disease (odds ratio = 1.75); and de novo lesions (odds ratio = 2.3). Multivariate predictors of major complications in unplanned native coronary artery procedures included high surgical risk (odds ratio = 3.08), and tortuous lesion (odds ratio = 2.41). In SVG lesions, the independent predictors of major complications for planned procedures included age (odds ratio = 1.09), high surgical risk (odds ratio = 4.34), and thrombus (odds ratio = 2.62). In native and SVG lesions, rates of major complications of planned procedures was acceptable (2.7-3.67%), but unplanned use of a new device was associated with a significantly higher rate of in-hospital complications (approximately 9%). Multivariate predictors for major ischemic complications included both clinical and lesion characteristics, and differed for native versus SVG lesions, as well as for planned versus unplanned procedures.