title: Recanalization of infrainguinal chronic total occlusions with the crosser system: results of the PATRIOT trial.
abstract: OBJECTIVE
  To evaluate the angiographic and functional outcomes of the Crosser chronic total occlusion (CTO) recanalization system used to facilitate crossing of infrainguinal occlusions resistant to conventional guidewire techniques.
  
  
  METHODS
  Eighty-five patients with a previous or concurrent failed attempt to cross a CTO using conventional guidewire techniques were enrolled at eight United States centers. Occlusions were at least 30 days old and ≤30 cm in length. Primary endpoints included advancement of the recanalization system into or through the occlusion gaining guidewire access in the distal vessel beyond the lesion, and 30-day freedom from clinical perforation requiring treatment.
  
  
  RESULTS
  The average age of occlusion was 16 months, the mean occlusion length was 117.5 ± 84.0 mm, 55.7% had unfavorable morphology for crossing, and 75% were moderately to severely calcified. Superficial femoral artery (SFA) occlusions were most commonly treated (61.2%), followed by popliteal artery (20%), and tibioperoneal (16.5%) occlusions. The CTO was crossed and the guidewire successfully advanced into the distal true lumen in 83.5% of cases. Following adjunctive therapy, 81.2% achieved a satisfactory angiographic result (≤50% residual stenosis). At 30 days post procedure, 98.8% of patients were free from clinical perforation.
  
  
  CONCLUSIONS
  Use of the Crosser CTO recanalization system facilitated crossing of guidewire-resistant, chronic, infrainguinal occlusions with minimal risk of clinically significant vessel perforation.
authors.affiliation: UC Davis Medical Center, UC Davis Vascular Center, 4860 Y St, Suite 3400, Sacramento, CA 95817 USA. john.laird@ucdmc.ucdavis.edu.
authors.forename: John
authors.initials: J
authors.lastname: Laird
authors.forename: James
authors.initials: J
authors.lastname: Joye
authors.forename: Naveen
authors.initials: N
authors.lastname: Sachdev
authors.forename: Paul
authors.initials: P
authors.lastname: Huang
authors.forename: Ronald
authors.initials: R
authors.lastname: Caputo
authors.forename: Imran
authors.initials: I
authors.lastname: Mohiuddin
authors.forename: John
authors.initials: J
authors.lastname: Runyon
authors.forename: Tony
authors.initials: T
authors.lastname: Das
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D017130:Angioplasty / Q000295:instrumentation*; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000628:therapy*; D002908:Chronic Disease; D018795:Device Approval; D004867:Equipment Design; D005260:Female; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000628:therapy*; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D012008:Recurrence; D017211:Treatment Failure; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration