The purpose of this study was to assess the potential of intraarterial ultrasound for in vivo recanalization of atherosclerotic total occlusions. Ultrasound energy at a frequency of 20 kHz was applied with a prototype solid wire probe to 12 surgically implanted occluded human atherosclerotic arterial xenografts, 9 of which were calcified, as well as to the intimal surface of 12 normal canine arteries. In both the normal canine arteries and the atherosclerotic occluded xenografts, there was no angiographic evidence of vasospasm, thrombosis or arterial dissection. Eleven of the 12 atherosclerotic complete arterial occlusions were resistant to passage of a conventional guide wire or probe without ultrasound energy. However, the occlusions were recanalized after administration of 15 s to 4 min (mean 1.5 +/- 1.3 min) of intermittent ultrasound energy. After ultrasound, 8 of the 12 vessels underwent balloon angioplasty. Angiographic residual stenosis after ultrasound alone was 62 +/- 24% and after combined ultrasound and balloon angioplasty, 29 +/- 13%. Although routine angiography did not reveal arterial emboli, high resolution cut films did demonstrate a few distal nonocclusive thrombi of a size similar to that reported with other recanalization methods. Histologic studies demonstrated changes similar to those after balloon angioplasty, with focal cracking of the fibrotic and calcified plaque. The findings demonstrate that ultrasound energy applied through a catheter delivery system can be used in vivo to open completely obstructed atherosclerotic vessels. These studies suggest that it might be clinically feasible to use the ultrasound probe to create a lumen, allowing subsequent balloon dilation.