title: Clinical trial of percutaneous peripheral ultrasound angioplasty.
abstract: OBJECTIVE
  The purpose of this study was to present follow-up data as well as short-term results on a larger clinical series of patients undergoing ultrasound angioplasty.
  
  
  BACKGROUND
  Previous pilot studies have demonstrated the feasibility of peripheral arterial ultrasound angioplasty.
  
  
  METHODS
  We performed percutaneous ultrasound angioplasty on 50 arterial lesions in 45 patients. Our ultrasound ablation system had a frequency of 19.5 kHz. A fixed-wire probe with 2- or 3-mm ball tips and a 3-mm over-the-wire probe were used to treat 40 femoral, 7 popliteal and 3 tibioperoneal lesions. Seventeen (34%) of the lesions were calcific. Thirty (86%) of 35 occluded segments, 0.5 to 28 cm long (mean 6.2 +/- 5.7), were recanalized.
  
  
  RESULTS
  In the 45 patent arteries, the stenosis decreased from 94 +/- 10% to 55 +/- 23% after ultrasound angioplasty and to 12 +/- 8% after balloon angioplasty. Mechanical arterial dissections (n = 4) and perforations (n = 4) without clinical consequence occurred only with the fixed non-over-the-wire probes. No evidence of embolism or vasospasm was detected; in fact, vasodilation occurred. There were no clinical manifestations of acute reocclusion. At 24 h, ankle-brachial indexes increased by 0.23 +/- 0.21 (range -0.27 to 0.72). Six- to 12-month clinical and ankle-brachial index follow-up data for 35 patients treated with ultrasound and adjunctive balloon angioplasty were indicative of restenosis in 7 patients (20%).
  
  
  CONCLUSIONS
  Our findings indicate that percutaneous peripheral ultrasound angioplasty 1) is useful for recanalization of fibrous, calcific and thrombotic arterial occlusions; 2) reduces arterial stenoses; and 3) has clinical and ankle-brachial index data indicative of a restenosis rate of 20% at 6 to 12 months in a small cohort of patients. A larger randomized series of patients will need to be studied to assess the impact of ultrasound ablation on restenosis.
authors.affiliation: Division of Cardiology, Cedars-Sinai Medical Center, Los Angeles, California 90048.
authors.forename: R J
authors.initials: RJ
authors.lastname: Siegel
authors.forename: P
authors.initials: P
authors.lastname: Gaines
authors.forename: J R
authors.initials: JR
authors.lastname: Crew
authors.forename: D C
authors.initials: DC
authors.lastname: Cumberland
mesh_terms: D000328:Adult; D000368:Aged; D000800:Angioplasty, Balloon / Q000295:instrumentation / Q000379:methods; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D005500:Follow-Up Studies; D006801:Humans; D007383:Intermittent Claudication / Q000628:therapy*; D007866:Leg / Q000098:blood supply; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery / Q000000981:diagnostic imaging; D011859:Radiography; D012008:Recurrence; D016896:Treatment Outcome; D014464:Ultrasonic Therapy / Q000295:instrumentation