title: Revascularization of lower extremity chronic total occlusions with a novel intraluminal recanalization device: results of the ReOpen study.
abstract: OBJECTIVE
  To report outcomes of a multicenter, nonrandomized study evaluating the safety and effectiveness of a guidewire-mounted mechanical recanalization device with a rotating distal tip (TruePath) in facilitating the crossing of infrainguinal chronic total occlusions (CTOs).
  
  
  METHODS
  Eligible patients had lower extremity ischemia and an angiographically confirmed occlusion, with no antegrade flow for at least 30 days, in an infrainguinal artery. Enrollment occurred when a previous or concurrent attempt to cross the CTO with a conventional guidewire had failed. A total of 85 patients with 85 lesions were enrolled; 61 (71.8%) target lesions were in the superficial femoral artery and 68 (80%) were considered moderately or heavily calcified. Clinical evaluations were assessed immediately post procedure and at 30-day follow-up.
  
  
  RESULTS
  Freedom from clinical perforation at the time of the procedure was achieved in 98.8% of patients. The device facilitated CTO crossing into the distal true lumen (technical success) in 68 (80.0%) patients, with subsequent distal guidewire positioning in 65 (76.5%). The average ABI (n=58) improved from 0.65 (range 0.35-1.20) at baseline to 1.00 (range 0.50-2.00) through 30-day follow-up. Symptoms improved in 70 (82.4%) patients upon treatment, and improvement was maintained in 57/70 (81.4%) through 30 days.
  
  
  CONCLUSIONS
  The ReOpen Study demonstrated that the TruePath device is safe and effective for facilitating crossing of CTOs resistant to conventional guidewire maneuvers.
authors: 1 AZ Saint Blasius, Dendermonde, Belgium.
authors: Marc
authors: M
authors: Bosiers
authors: Juan
authors: J
authors: Diaz-Cartelle
authors: Dierk
authors: D
authors: Scheinert
authors: Patrick
authors: P
authors: Peeters
authors: Keith D
authors: KD
authors: Dawkins
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D055109:Ankle Brachial Index; D002908:Chronic Disease; D003251:Constriction, Pathologic; D057510:Endovascular Procedures / Q000009:adverse effects / Q000295:instrumentation*; D004867:Equipment Design; D005060:Europe; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000503:physiopathology; D006801:Humans; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D058729:Peripheral Arterial Disease / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D011446:Prospective Studies; D011859:Radiography; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency