title: Infrainguinal CTO Recanalization Assessed by Intravascular Ultrasound: Results of the CENTRAL Study.
abstract: OBJECTIVE
  CENTRAL was a prospective, multicenter, 100 patient study designed to evaluate the ability of a recanalization catheter system to cross chronic total occlusions (CTOs) of the superficial femoral artery while staying within the central vessel lumen.
  
  
  METHODS
  The primary endpoint was the successful crossing of a CTO (≥90% of the length) with the recanalization catheter in the central lumen of the superficial femoral artery in at least one-half of the studied patient population, confirmed by intravascular ultrasound. Secondary endpoints included standardized anatomic damage assessment (the TAPE method) and an assessment of the relationship between the percent of CTO crossing and TAPE scores to the rate of target-lesion revascularization (TLR) at 30 days and 6 months.
  
  
  RESULTS
  The mean age of the occlusions was 16.6 ± 22.28 months (range, 1-120 months), the average occlusion length reported by the sites was 132.1 ± 87.69 mm (range, 4-300 mm), and a majority of lesions were moderately (42.0%) or severely (32.0%) calcified. In 43/85 (50.6%) of the evaluable intravascular ultrasound images, the recanalization catheter successfully navigated the central lumen of the CTO (ie, ≥90% luminal crossing) with >50% luminal crossing in 64/85 (75.3%) of cases. The 6-month TLR rate was significantly lower in patients where the CTO was crossed ≥90% in the central vessel lumen (4.7%) compared with crossings <90% (20.6%; P=.04). The 6-month TLR rate was 3.5% in patients with a favorable TAPE score of 0-4 and 36.8% with an unfavorable TAPE score of 5-8 (P<.001).
  
  
  CONCLUSIONS
  Use of a recanalization catheter in complex superficial femoral artery CTO crossings achieved intraluminal crossings in >50% of cases and decreased anatomic damage, which appeared to offer a significant advantage in 6-month TLR rates.
authors.affiliation: St. John Hospital and Medical Center, 22101 Moross Road, Detroit, MI 48236 USA. toreyj01@yahoo.com.
authors.forename: James
authors.initials: J
authors.lastname: Torey
authors.forename: Anwar
authors.initials: A
authors.lastname: Zaitoun
authors.forename: Thomas
authors.initials: T
authors.lastname: Lalonde
authors.forename: John
authors.initials: J
authors.lastname: Runyon
authors.forename: Jihad
authors.initials: J
authors.lastname: Mustapha
authors.forename: Thomas
authors.initials: T
authors.lastname: Davis
mesh_terms: D000368:Aged; D001157:Arterial Occlusive Diseases / Q000175:diagnosis / Q000209:etiology / Q000601:surgery; D002406:Catheterization, Peripheral / Q000295:instrumentation / Q000379:methods; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000473:pathology / Q000601:surgery; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000209:etiology / Q000601:surgery; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D010043:Outcome and Process Assessment, Health Care; D016491:Peripheral Vascular Diseases / Q000150:complications; D012720:Severity of Illness Index; D018084:Ultrasonography, Interventional / Q000379:methods*; D061205:Vascular Calcification