Safety and efficacy of a novel device for treatment of thrombotic and atherosclerotic lesions in native coronary arteries and saphenous vein grafts: Results from the multicenter X‐sizer for treatment of thrombus and atherosclerosis in coronary applications trial (X‐TRACT) study

Intervention in thrombotic lesions and diseased saphenous vein grafts frequently results in thromboembolic complications, including no‐reflow, distal branch occlusion, periprocedural MI, and death. The utility of a novel thromboatherectomy device, the X‐Sizer, was tested in 50 consecutive patients at nine U.S. centers. A total of 61 lesions were treated in 31 vein grafts and 19 native coronary arteries; thrombus was present in 78% of lesions, and TIMI 0–1 flow in 21%. TIMI 3 flow improved from 57% at baseline to 94% postprocedure. No patient developed visible distal thromboemboli, side‐branch occlusion, or reduced antegrade flow. Thirty‐day events included one death (2.0%), Q‐ or non–Q‐wave MI in 4.0%, TVR in 6.0%, and any MACE in 6.0%. We conclude that the use of the X‐Sizer prior to percutaneous intervention is safe in high‐risk vein grafts and thrombotic lesions and results in a low rate of adverse events compared to historical controls. Cathet Cardiovasc Intervent 2003;58:419–427. © 2003 Wiley‐Liss, Inc.